{"id":"grazoprevir","rwe":[],"tags":[{"label":"Small Molecule","category":"modality"},{"label":"J05AP11","category":"atc"},{"label":"Active","category":"status"},{"label":"Chronic hepatitis C","category":"indication"},{"label":"Merck Sharp Dohme","category":"company"},{"label":"Approved 2010s","category":"decade"},{"label":"Anti-Infective Agents","category":"pharmacology"},{"label":"Antiviral Agents","category":"pharmacology"}],"phase":"discontinued","safety":{"safetySignals":[{"llr":59.122,"date":"","count":7,"signal":"Pancreas transplant rejection","source":"DrugCentral FAERS","actionTaken":"Reported 7 times (LLR=59)"}],"commonSideEffects":[{"effect":"Pancreas transplant rejection","drugRate":"LLR 59","severity":"common"}]},"trials":[],"aliases":[],"company":"Merck & Co.","patents":[{"source":"FDA Orange Book via DrugCentral","expires":"2031-05-04","territory":"US","patentNumber":"8871759"},{"source":"FDA Orange Book via DrugCentral","expires":"2029-07-24","territory":"US","patentNumber":"7973040"}],"pricing":[],"allNames":"zepatier","offLabel":[],"synonyms":["grazoprevir","grazoprevir hydrate","MK-5172","MK5172","MK 5172"],"timeline":[{"date":"2016-01-28","type":"positive","source":"DrugCentral","milestone":"FDA approval (Merck Sharp Dohme)"}],"aiSummary":"Zepatier (Grazoprevir) is a small molecule medication developed by Merck Sharp Dohme, approved by the FDA in 2016 for the treatment of chronic hepatitis C. It is a combination therapy that works by inhibiting the NS3/4A protease enzyme, which is essential for the replication of the hepatitis C virus. Zepatier is a patented medication, and its commercial status is not off-patent. Key safety considerations include potential interactions with other medications and monitoring for liver function. In plain English, Zepatier works by blocking a specific enzyme that the hepatitis C virus needs to multiply.","approvals":[{"date":"2016-01-28","orphan":false,"company":"MERCK SHARP DOHME","regulator":"FDA"}],"brandName":"Zepatier","ecosystem":[{"indication":"Chronic hepatitis C","otherDrugs":[{"name":"boceprevir","slug":"boceprevir","company":"Merck Sharp Dohme"},{"name":"daclatasvir","slug":"daclatasvir","company":"Bristol Myers Squibb"},{"name":"dasabuvir","slug":"dasabuvir","company":"Abbvie Inc"},{"name":"elbasvir","slug":"elbasvir","company":"Merck Sharp Dohme"}],"globalPrevalence":58000000}],"mechanism":{"novelty":"Follow-on","modality":"Small Molecule","explanation":"Imagine the hepatitis C virus is like a machine that needs a specific tool to work. Zepatier is like a lock that blocks the tool, preventing the machine from making copies of itself. This helps to slow down the spread of the virus in the body.","oneSentence":"Zepatier blocks the NS3/4A protease enzyme, preventing the hepatitis C virus from replicating.","technicalDetail":"Grazoprevir is a potent inhibitor of the NS3/4A protease enzyme, which is essential for the replication of the hepatitis C virus. It works by binding to the active site of the enzyme, preventing it from cleaving the viral polyprotein and thereby inhibiting viral replication."},"_wikipedia":{"url":"https://en.wikipedia.org/wiki/Elbasvir%2Fgrazoprevir","title":"Elbasvir/grazoprevir","extract":"Elbasvir/grazoprevir, sold under the brand name Zepatier, is a fixed-dose combination for the treatment of hepatitis C, containing elbasvir and grazoprevir. It is used to treat chronic hepatitis C virus (HCV) genotypes 1 or 4 infection in both treatment-naïve and treatment-experienced patients.","wiki_society_and_culture":"==Society and culture==\n===Patents===\nU.S. Patent No. 8871759 was published in 2014 for the specified compounds useful for hepatitis C virus NS5A inhibitors. The patent protects Merck's formulation for the drug and its other associated salt forms, hydrates, solvates, prodrugs and isomers. U.S. Patent No. 7973040 was published in 2011. The patent protects the invention by Merck of the macrocyclic compound within the formula as an inhibitor for NS3 protease. The patent describes the formulation of the compound and its salts, along with its uses and potential implications as an HCV antiviral treatment.\n\n===Commercialization===\nElbasvir/grazoprevir was FDA approved in the United States, and has been approved for use in the European Union, Canada, Japan, Australia, Saudi Arabia, Israel, and Switzerland. Zepatier is one of a few non-interferon therapies that are market-available. Competing treatments include Gilead's Harvoni (sofosbuvir and ledipasvir) and AbbVie's Viekira Pak (ombitasvir, paritaprevir, and ritonavir). Sale projections for Zepatier are $636 million in 2016 and rising to $1.5 billion by 2020.\nWith Merck's release of Zepatier early in 2016, they saw large bumps in share prices in quarters 1 and 2, but are expected to drop down a bit. Zepatier does not have as strong a market hold as other competitive HCV treatments.\n\n=== Economics ===\nEstimated costs for a 12-week treatment of elbasvir/grazoprevir are upwards of $54,600. Other treatments that work in a similar manner have effectively more costs. Some treatments for Hepatitis C are on the cheaper side, in some instances as low as $8,400. Additional ribavirin costs can add between $500 and $900. These cheaper prescriptions are however interferon-based treatments and do not target every genotype of the HCV. These regimens were the priority treatment before 2011. Two examples of these treatments are alfa-2a and alfa-2b costing $9250 and $8400, respectively."},"commercial":{"launchDate":"2016","_launchSource":"DrugCentral (FDA 2016-01-28, MERCK SHARP DOHME)"},"references":[{"id":1,"url":"https://drugcentral.org/drugcard/5081","fields":["approvals","synonyms","ATC","PK","indications","contraindications","DDIs","targets","patents","FAERS"],"source":"DrugCentral"},{"id":2,"url":"https://clinicaltrials.gov/search?intr=GRAZOPREVIR","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":3,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=GRAZOPREVIR","fields":["publications"],"source":"PubMed/NCBI"},{"id":4,"url":"https://en.wikipedia.org/wiki/Elbasvir%2Fgrazoprevir","fields":["history","overview"],"source":"Wikipedia"}],"_enrichedAt":"2026-03-30T13:49:46.364832","biosimilars":[],"competitors":[{"drugName":"ribavirin","drugSlug":"ribavirin","fdaApproval":"1985-12-31","genericCount":8,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"telaprevir","drugSlug":"telaprevir","fdaApproval":"2011-05-23","patentExpiry":"May 30, 2028","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"boceprevir","drugSlug":"boceprevir","fdaApproval":"2011-05-13","patentExpiry":"Nov 11, 2027","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"simeprevir","drugSlug":"simeprevir","fdaApproval":"2013-11-22","patentExpiry":"Sep 5, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"daclatasvir","drugSlug":"daclatasvir","fdaApproval":"2015-07-24","patentExpiry":"Jun 13, 2031","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"sofosbuvir","drugSlug":"sofosbuvir","fdaApproval":"2013-12-06","patentExpiry":"Sep 26, 2029","patentStatus":"Patent protected","relationship":"same-class"},{"drugName":"dasabuvir","drugSlug":"dasabuvir","fdaApproval":"2014-12-19","relationship":"same-class"},{"drugName":"elbasvir","drugSlug":"elbasvir","fdaApproval":"2016-01-28","relationship":"same-class"},{"drugName":"ledipasvir","drugSlug":"ledipasvir","fdaApproval":"2014-10-10","relationship":"same-class"},{"drugName":"ombitasvir","drugSlug":"ombitasvir","fdaApproval":"2014-12-19","relationship":"same-class"},{"drugName":"paritaprevir","drugSlug":"paritaprevir","fdaApproval":"2014-12-19","relationship":"same-class"},{"drugName":"ritonavir","drugSlug":"ritonavir","fdaApproval":"1996-03-01","genericCount":6,"patentStatus":"Off-patent — generic available","relationship":"same-class"},{"drugName":"velpatasvir","drugSlug":"velpatasvir","fdaApproval":"2016-06-28","relationship":"same-class"}],"genericName":"grazoprevir","indications":{"approved":[{"name":"Chronic hepatitis C","source":"DrugCentral","snomedId":128302006,"regulator":"FDA","usPrevalence":2400000,"globalPrevalence":58000000,"prevalenceMethod":"curated","prevalenceSource":"WHO, 2024"}],"offLabel":[],"pipeline":[]},"drugCategory":"active","labelChanges":[],"relatedDrugs":[{"drugId":"ribavirin","brandName":"ribavirin","genericName":"ribavirin","approvalYear":"1985","relationship":"same-class"},{"drugId":"telaprevir","brandName":"telaprevir","genericName":"telaprevir","approvalYear":"2011","relationship":"same-class"},{"drugId":"boceprevir","brandName":"boceprevir","genericName":"boceprevir","approvalYear":"2011","relationship":"same-class"},{"drugId":"simeprevir","brandName":"simeprevir","genericName":"simeprevir","approvalYear":"2013","relationship":"same-class"},{"drugId":"daclatasvir","brandName":"daclatasvir","genericName":"daclatasvir","approvalYear":"2015","relationship":"same-class"},{"drugId":"sofosbuvir","brandName":"sofosbuvir","genericName":"sofosbuvir","approvalYear":"2013","relationship":"same-class"},{"drugId":"dasabuvir","brandName":"dasabuvir","genericName":"dasabuvir","approvalYear":"2014","relationship":"same-class"},{"drugId":"elbasvir","brandName":"elbasvir","genericName":"elbasvir","approvalYear":"2016","relationship":"same-class"},{"drugId":"ledipasvir","brandName":"ledipasvir","genericName":"ledipasvir","approvalYear":"2014","relationship":"same-class"},{"drugId":"ombitasvir","brandName":"ombitasvir","genericName":"ombitasvir","approvalYear":"2014","relationship":"same-class"}],"trialDetails":[{"nctId":"NCT02940496","phase":"PHASE2","title":"Pembrolizumab (MK-3475) in Hepatocellular Carcinoma","status":"COMPLETED","sponsor":"M.D. Anderson Cancer Center","startDate":"2016-12-09","conditions":["BCLC Stage B Hepatocellular Carcinoma","BCLC Stage C Hepatocellular Carcinoma","Hepatitis C Infection","Refractory Liver Carcinoma","Stage III Hepatocellular Carcinoma AJCC v7","Stage IIIA Hepatocellular Carcinoma AJCC v7","Stage IIIB Hepatocellular Carcinoma AJCC v7","Stage IIIC Hepatocellular Carcinoma AJCC v7","Stage IV Hepatocellular Carcinoma AJCC v7","Stage IVA Hepatocellular Carcinoma AJCC v7","Stage IVB Hepatocellular Carcinoma AJCC v7"],"enrollment":15,"completionDate":"2023-08-09"},{"nctId":"NCT02890719","phase":"PHASE3","title":"Pilot Study Evaluate Efficacy of Grazoprevir + Elbasvir for 12 or 16 Weeks in Liver Transplant Recipients.","status":"WITHDRAWN","sponsor":"Fundacion Clinic per a la Recerca Biomédica","startDate":"2016-08-03","conditions":["Liver Transplantation","Hepatitis C"],"enrollment":0,"completionDate":"2017-06-01"},{"nctId":"NCT04048850","phase":"","title":"Zepatier in Patients with Substance Use","status":"COMPLETED","sponsor":"University of Illinois at Chicago","startDate":"2019-09-20","conditions":["Hepatitis C","Hiv","Coinfection, HIV","Substance Use Disorders"],"enrollment":25,"completionDate":"2022-09-09"},{"nctId":"NCT01353911","phase":"PHASE2","title":"Grazoprevir (MK-5172) Administered With Peginterferon and Ribavirin in Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-003)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-06-27","conditions":["Hepatitis C, Chronic"],"enrollment":368,"completionDate":"2015-03-10"},{"nctId":"NCT02613403","phase":"PHASE2","title":"Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2015-12-10","conditions":["Hepatitis","Hepatitis C","Digestive System Diseases","Flaviviridae Infections","Hepatitis, Viral, Human","Liver Diseases","RNA Virus Infections","Virus Diseases"],"enrollment":94,"completionDate":"2017-03-27"},{"nctId":"NCT01440595","phase":"PHASE2","title":"Grazoprevir (MK-5172) With Peg-Interferon and Ribavirin in Participants With Chronic Genotype 2 or 3 Hepatitis C (MK-5172-012)","status":"TERMINATED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-11-28","conditions":["Hepatitis C, Chronic"],"enrollment":5,"completionDate":"2012-05-01"},{"nctId":"NCT02902120","phase":"PHASE4","title":"HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2017-05-01","conditions":["Hepatitis C","Renal Insufficiency, Chronic","Disorder of Transplanted Kidney"],"enrollment":21,"completionDate":"2022-06-08"},{"nctId":"NCT02743897","phase":"PHASE1,PHASE2","title":"Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2016-05-01","conditions":["End Stage Renal Disease"],"enrollment":62,"completionDate":"2022-12"},{"nctId":"NCT03379506","phase":"PHASE2","title":"Elbasvir (EBR)/Grazoprevir (GZR) in Pediatric Participants With Chronic Hepatitis C Infection (MK-5172-079)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2018-01-25","conditions":["HCV Infection"],"enrollment":57,"completionDate":"2020-07-23"},{"nctId":"NCT03823911","phase":"PHASE4","title":"Cardiovascular Disease in HIV and Hepatitis C: Risk Outcomes After Hepatitis C Eradication","status":"COMPLETED","sponsor":"University of Maryland, Baltimore","startDate":"2018-11-18","conditions":["Cardiovascular Diseases","Hepatitis C","Hiv"],"enrollment":87,"completionDate":"2022-12-31"},{"nctId":"NCT03797066","phase":"PHASE4","title":"ATTIC - Access To Treat in the Community","status":"TERMINATED","sponsor":"King's College Hospital NHS Trust","startDate":"2019-03-23","conditions":["Hepatitis C, Chronic"],"enrollment":13,"completionDate":"2020-11-30"},{"nctId":"NCT03724149","phase":"PHASE1,PHASE2","title":"Transplanting Hepatitis C Lungs Into Negative Lung Recipients","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2018-12-12","conditions":["Lung Diseases"],"enrollment":10,"completionDate":"2022-12-31"},{"nctId":"NCT02858050","phase":"","title":"Portal-724 MEMS for Medication Adherence Patients Taking HCV Medications","status":"COMPLETED","sponsor":"Saint Michael's Medical Center","startDate":"2016-09-09","conditions":["Adherence"],"enrollment":40,"completionDate":"2018-01-25"},{"nctId":"NCT03496233","phase":"PHASE3","title":"Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients","status":"COMPLETED","sponsor":"Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo","startDate":"2018-09-19","conditions":["Chronic HCV Hepatitis"],"enrollment":75,"completionDate":"2020-06-20"},{"nctId":"NCT03144440","phase":"","title":"Real World Experience of Chronic Hepatitis C (CHC) Treatment in Israel","status":"COMPLETED","sponsor":"Carmel Medical Center","startDate":"2016-12-13","conditions":["Hepatitis C"],"enrollment":200,"completionDate":"2021-01-01"},{"nctId":"NCT02333292","phase":"","title":"Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions","status":"COMPLETED","sponsor":"Valme University Hospital","startDate":"2014-12","conditions":["Chronic Hepatitis C Infection"],"enrollment":1128,"completionDate":"2017-06-30"},{"nctId":"NCT01667081","phase":"","title":"Durability of Virologic Response and/or Viral Resistance Patterns in Participants With Chronic Hepatitis C Who Have Been Previously Treated With Grazoprevir (MK-5172) (MK-5172-017)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-10-17","conditions":["Hepatitis C"],"enrollment":2438,"completionDate":"2021-03-31"},{"nctId":"NCT03365635","phase":"PHASE4","title":"Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2019-09-22","conditions":["Hepatitis C","Hemodialysis","Nosocomial Infection"],"enrollment":6,"completionDate":"2020-09-01"},{"nctId":"NCT02786537","phase":"PHASE4","title":"Study of Oral Treatments for Hepatitis C","status":"COMPLETED","sponsor":"University of Florida","startDate":"2016-06","conditions":["Chronic Hepatitis C"],"enrollment":1275,"completionDate":"2020-09-02"},{"nctId":"NCT03146741","phase":"PHASE1,PHASE2","title":"Zepatier For Treatment Of Hepatitis C-Negative Patients Who Receive Heart Transplants From Hepatitis C-Positive Donors (HCV)","status":"COMPLETED","sponsor":"University of Pennsylvania","startDate":"2017-05-16","conditions":["Heart Failure"],"enrollment":20,"completionDate":"2019-11-30"},{"nctId":"NCT03236506","phase":"PHASE2","title":"A Direct obserVed therApy vs fortNightly CollEction Study for HCV Treatment - ADVANCE HCV Study","status":"COMPLETED","sponsor":"University of Dundee","startDate":"2018-01-19","conditions":["Hepatitis C"],"enrollment":129,"completionDate":"2020-10-28"},{"nctId":"NCT03127358","phase":"NA","title":"Smartphone Based aDOT Treatment With Fixed-Dose Elbasvir and Grazoprevir in PWIDs","status":"COMPLETED","sponsor":"Albert Einstein College of Medicine","startDate":"2017-11-14","conditions":["Hepatitis C","Medication Adherence"],"enrollment":11,"completionDate":"2019-02-06"},{"nctId":"NCT04952207","phase":"","title":"Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C","status":"UNKNOWN","sponsor":"Qing XIe","startDate":"2019-03-06","conditions":["Hepatitis C, Chronic"],"enrollment":300,"completionDate":"2021-08-31"},{"nctId":"NCT03723824","phase":"PHASE4","title":"Grazoprevir/Elbasvir for Genotype 1b Chronic Hepatitis C After Liver or Kidney Transplantation","status":"TERMINATED","sponsor":"Taichung Veterans General Hospital","startDate":"2019-02-14","conditions":["Chronic Hepatitis c","Liver Transplant Infection","Kidney Transplant Infection"],"enrollment":14,"completionDate":"2021-03-13"},{"nctId":"NCT02133131","phase":"PHASE2","title":"Efficacy and Safety of Grazoprevir (MK-5172), Elbasvir (MK-8742), and Sofosbuvir for Chronic Infection With Hepatitis C Virus Genotypes 1 and 3 (MK-5172-074)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-06-13","conditions":["Hepatitis C"],"enrollment":143,"completionDate":"2016-02-01"},{"nctId":"NCT02105701","phase":"PHASE3","title":"Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) With or Without Ribavirin for Participants With Hepatitis C Genotype 1, 4, or 6 Infections Who Have Failed Prior Treatment With Pegylated Interferon + Ribavirin (MK-5172-068)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-06-05","conditions":["Hepatitis C Infection"],"enrollment":420,"completionDate":"2015-06-19"},{"nctId":"NCT02105662","phase":"PHASE3","title":"An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus in Participants Who Are Co-Infected With Human Immunodeficiency Virus:C-EDGE CO-INFXN (MK-5172-061)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-06-03","conditions":["Chronic Hepatitis C"],"enrollment":218,"completionDate":"2015-05-22"},{"nctId":"NCT01717326","phase":"PHASE2","title":"A Study of the Combination Regimen Grazoprevir (MK-5172) and Elbasvir (MK-8742) ± Ribavirin in Participants With Chronic Hepatitis C (MK-5172-035)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2013-02-07","conditions":["Hepatitis C"],"enrollment":573,"completionDate":"2015-05-06"},{"nctId":"NCT01710501","phase":"PHASE2","title":"A Study of Different Doses of Grazoprevir (MK-5172) Given With Pegylated Interferon Alfa-2b and Ribavirin to Treatment-Naïve Participants With Chronic Hepatitis C (MK-5172-038)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-12-07","conditions":["Chronic Hepatitis C (CHC)"],"enrollment":87,"completionDate":"2014-01-29"},{"nctId":"NCT01932762","phase":"PHASE2","title":"Efficacy and Safety of Combination Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin (RBV) in Genotype 2 Hepatitis C Infection (MK-5172-047)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2013-10-01","conditions":["Hepatitis C"],"enrollment":98,"completionDate":"2014-12-04"},{"nctId":"NCT03578640","phase":"PHASE3","title":"Eight Weeks of Elbasvir/Grazoprevir in the Treatment of HCV Genotype 4","status":"COMPLETED","sponsor":"King Fahad Medical City","startDate":"2018-07-01","conditions":["Hepatitis C, Chronic"],"enrollment":30,"completionDate":"2020-06-30"},{"nctId":"NCT03093415","phase":"PHASE4","title":"Hepatitis C Treatment in PWIDs: MAT or Syringe Exchange Assisted-therapy vs Standard of Care","status":"COMPLETED","sponsor":"Oregon Health and Science University","startDate":"2017-05-30","conditions":["Hepatitis C","Substance Use Disorders","Substance Abuse, Intravenous"],"enrollment":100,"completionDate":"2019-06-06"},{"nctId":"NCT03817619","phase":"PHASE1","title":"Bioequivalence Study of Crushed Elbasvir/Grazoprevir Compared to the Whole Tablet","status":"COMPLETED","sponsor":"Radboud University Medical Center","startDate":"2019-03-28","conditions":["Hepatitis C","Deglutition Disorders"],"enrollment":11,"completionDate":"2019-07-30"},{"nctId":"NCT02973503","phase":"PHASE3","title":"Study to Investigate the Efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, With Non-severe Fibrosis","status":"COMPLETED","sponsor":"University Hospital, Clermont-Ferrand","startDate":"2017-01-11","conditions":["Chronic HCV Infection"],"enrollment":117,"completionDate":"2019-04"},{"nctId":"NCT04546802","phase":"PHASE3","title":"HepATocellular Cancer Hcv Therapy Study","status":"WITHDRAWN","sponsor":"Bayside Health","startDate":"2019-09","conditions":["Hepatocellular Carcinoma","Hepatoma","Liver Cell Carcinoma","Hepatitis C"],"enrollment":0,"completionDate":"2023-06"},{"nctId":"NCT03111108","phase":"PHASE4","title":"Efficacy and Safety of Elbasvir (MK-8742) + Grazoprevir (MK-5172) in Treatment-Naïve/Treatment-Experienced (TN/TE) French Participants With Hepatitis C Virus (HCV) Genotype 4 (GT4) Infection (MK-5172-096)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2017-06-20","conditions":["Hepatitis C Virus (HCV) Infection"],"enrollment":117,"completionDate":"2018-10-15"},{"nctId":"NCT02945150","phase":"PHASE4","title":"Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant","status":"COMPLETED","sponsor":"Massachusetts General Hospital","startDate":"2017-02-01","conditions":["Renal Failure"],"enrollment":8,"completionDate":"2020-03-05"},{"nctId":"NCT03381859","phase":"PHASE4","title":"Clinical Trial to eLiminate HCV-infection in Treatment-naïve, Renally Impaired EgyptiAn Patients on Renal Dialysis, With Chronic Hepatitis C Genotype 4","status":"WITHDRAWN","sponsor":"University of Maryland, Baltimore","startDate":"2019-12-01","conditions":["Hepatitis C Virus Infection, Response to Therapy of"],"enrollment":0,"completionDate":"2020-06-01"},{"nctId":"NCT03249194","phase":"EARLY_PHASE1","title":"Hepatitis C Virus Donor Positive Kidney Transplantation for Hepatitis C Virus Negative Recipients","status":"COMPLETED","sponsor":"Virginia Commonwealth University","startDate":"2017-08-17","conditions":["Kidney Transplant","Hepatitis C"],"enrollment":25,"completionDate":"2020-03-15"},{"nctId":"NCT03420300","phase":"PHASE4","title":"EBR/GZR for HCV-1b Patients Receiving Hemodialysis","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2018-06-05","conditions":["Hepatitis C"],"enrollment":40,"completionDate":"2020-02-03"},{"nctId":"NCT02940691","phase":"PHASE4","title":"Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs","status":"TERMINATED","sponsor":"Kirby Institute","startDate":"2017-05-01","conditions":["Hepatitis C"],"enrollment":32,"completionDate":"2018-11-01"},{"nctId":"NCT03791814","phase":"PHASE4","title":"A Prospective Cohort Study to Improve HCV Care in Dialysis Patients","status":"WITHDRAWN","sponsor":"Albert Einstein Healthcare Network","startDate":"2019-01-01","conditions":["Hepatitis C"],"enrollment":0,"completionDate":"2019-06-30"},{"nctId":"NCT03037151","phase":"PHASE4","title":"Safety and Efficacy of Grazoprevir and Elbasvir for GT1ang GT6 With and Without HIV","status":"UNKNOWN","sponsor":"The HIV Netherlands Australia Thailand Research Collaboration","startDate":"2018-08-01","conditions":["Compensated Cirrhosis"],"enrollment":100,"completionDate":"2020-12-31"},{"nctId":"NCT02886624","phase":"PHASE2","title":"Short Duration Therapy of Acute Hepatitis C Genotypes 1 or 4","status":"COMPLETED","sponsor":"Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba","startDate":"2017-05-31","conditions":["Acute Hepatitis C","HIV"],"enrollment":30,"completionDate":"2019-09-16"},{"nctId":"NCT02895958","phase":"PHASE4","title":"The Dublin Zepatier Study","status":"TERMINATED","sponsor":"Mater Misericordiae University Hospital","startDate":"2018-03-15","conditions":["Hepatitis C"],"enrollment":3,"completionDate":"2019-12-06"},{"nctId":"NCT02105688","phase":"PHASE3","title":"An Efficacy and Safety Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in the Treatment of Chronic Hepatitis C Virus (HCV) Genotype (GT)1, 4, or 6 Infection in Treatment-Naïve Participants Who Are on Opiate Substitution Therapy (MK-5172-062)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-09-02","conditions":["Chronic Hepatitis C"],"enrollment":301,"completionDate":"2018-12-04"},{"nctId":"NCT04063839","phase":"","title":"HCV Treatment in a Low-threshold Clinic","status":"UNKNOWN","sponsor":"University Hospital, Akershus","startDate":"2015-01","conditions":["Hepatitis C","Substance Use Disorders"],"enrollment":300,"completionDate":"2022-12"},{"nctId":"NCT03221582","phase":"PHASE4","title":"Impact of Hepatitis C Therapy and Bone Health","status":"TERMINATED","sponsor":"Dallas VA Medical Center","startDate":"2017-08-28","conditions":["Human Immunodeficiency Virus","Hepatitis C"],"enrollment":6,"completionDate":"2018-11-30"},{"nctId":"NCT02601573","phase":"PHASE2","title":"Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic Hepatitis C Virus (HCV) Genotype 3 (GT3) Infection (MK-5172-083)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2016-01-05","conditions":["Hepatitis C"],"enrollment":101,"completionDate":"2017-01-06"},{"nctId":"NCT04047680","phase":"","title":"eGFR Evolution in HCV Patients Receiving SOF-based or SOF-free DAAs","status":"COMPLETED","sponsor":"National Taiwan University Hospital","startDate":"2015-02","conditions":["Hepatitis C","Renal Disease","Viral Hepatitis C"],"enrollment":441,"completionDate":"2019-06"},{"nctId":"NCT03423641","phase":"","title":"An Observational Study of the Safety of Direct-acting Antivirals in Patients With Hepatitis C","status":"COMPLETED","sponsor":"Kaiser Permanente","startDate":"2011-01-01","conditions":["Hepatitis C, Chronic"],"enrollment":33808,"completionDate":"2017-12-31"},{"nctId":"NCT02332720","phase":"PHASE2","title":"Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Virus (HCV) Genotype (GT) 3, GT4, GT5, and GT6 Infection (MK-3682-012)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2015-01-28","conditions":["Hepatitis C"],"enrollment":413,"completionDate":"2017-05-03"},{"nctId":"NCT02332707","phase":"PHASE2","title":"Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) for Chronic Hepatitis C Genotype (GT)1 and GT2 Infection (MK-3682-011)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2015-01-22","conditions":["Hepatitis C"],"enrollment":443,"completionDate":"2016-12-06"},{"nctId":"NCT02600325","phase":"PHASE3","title":"Dutch Acute HCV in HIV Study (DAHHS-2): Grazoprevir/Elbasvir for Acute HCV","status":"COMPLETED","sponsor":"Erasmus Medical Center","startDate":"2016-02","conditions":["Acute Hepatitis C","Human Immunodeficiency Virus","Hepatitis C"],"enrollment":80,"completionDate":"2019-01-11"},{"nctId":"NCT02115321","phase":"PHASE2,PHASE3","title":"Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Child-Pugh (CP)-B Hepatic Insufficiency (MK-5172-059)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-05-09","conditions":["Chronic Hepatitis C"],"enrollment":40,"completionDate":"2015-06-16"},{"nctId":"NCT01937975","phase":"PHASE1","title":"The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2013-09-06","conditions":["Chronic Hepatitis C","Renal Impairment"],"enrollment":24,"completionDate":"2013-12-17"},{"nctId":"NCT03144635","phase":"PHASE4","title":"A Study for G1b CHC Patients With CKD-3 Treated With Grazoprevir Plus Elbasvir","status":"COMPLETED","sponsor":"Kyushu University","startDate":"2017-04-01","conditions":["Hepatitis C Viral","Chronic Kidney Disease stage3"],"enrollment":80,"completionDate":"2018-09-20"},{"nctId":"NCT03887637","phase":"","title":"Real-world Effectiveness and Safety of Treatment With DAAs in Patients With CHC(Chronic Hepatitis C)","status":"UNKNOWN","sponsor":"Third Affiliated Hospital, Sun Yat-Sen University","startDate":"2019-03-30","conditions":["Chronic Hepatitis C"],"enrollment":180,"completionDate":"2019-09-30"},{"nctId":"NCT03706222","phase":"","title":"Drug-Drug Interactions of Grazoprevir/Elbasvir in Taiwan","status":"COMPLETED","sponsor":"National Cheng-Kung University Hospital","startDate":"2018-10-22","conditions":["Drug Interaction Potentiation"],"enrollment":400,"completionDate":"2019-02-25"},{"nctId":"NCT02897596","phase":"PHASE3","title":"Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients","status":"UNKNOWN","sponsor":"Fundacion Clinic per a la Recerca Biomédica","startDate":"2017-04-28","conditions":["Hepatitis C","HIV"],"enrollment":62,"completionDate":"2019-10-30"},{"nctId":"NCT03111966","phase":"","title":"Effectiveness, Safety and Clinical Outcomes of Elbasvir/Grazoprevir: Results From a Spanish Real World Cohort","status":"COMPLETED","sponsor":"Hepa C","startDate":"2017-03-31","conditions":["Hepatitis C"],"enrollment":130,"completionDate":"2017-11-30"},{"nctId":"NCT02251990","phase":"PHASE3","title":"Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination in Treatment-Naïve Hepatitis C Virus Participants (MK-5172-067)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2015-01-28","conditions":["Hepatitis C"],"enrollment":489,"completionDate":"2017-04-10"},{"nctId":"NCT02661126","phase":"PHASE1","title":"Pharmacokinetics of MK-3682B in Participants With Moderate to Severe Renal Insufficiency (MK-3682B-030)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2016-01-19","conditions":["Hepatitis C"],"enrollment":16,"completionDate":"2016-08-26"},{"nctId":"NCT03186365","phase":"PHASE3","title":"8 Weeks Versus 12 Weeks of Elbasvir/Grazoprevir in Treatment-naïve CHC With Mild Fibrosis","status":"COMPLETED","sponsor":"Kaohsiung Medical University Chung-Ho Memorial Hospital","startDate":"2017-06-12","conditions":["Hepatitis C, Chronic"],"enrollment":82,"completionDate":"2018-09-19"},{"nctId":"NCT03026023","phase":"PHASE4","title":"Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant","status":"WITHDRAWN","sponsor":"Raymond T. Chung, MD","startDate":"2018-08-01","conditions":["Cardiac Transplant Disorder","Hepatitis C"],"enrollment":0,"completionDate":"2021-06-30"},{"nctId":"NCT03093740","phase":"PHASE4","title":"Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant","status":"WITHDRAWN","sponsor":"Massachusetts General Hospital","startDate":"2018-10-01","conditions":["Renal Failure Chronic","Hepatitis C"],"enrollment":0,"completionDate":"2021-01-31"},{"nctId":"NCT03098121","phase":"PHASE4","title":"Efficacy and Tolerability of Grazoprevir and Elbasvir in Patients With Chronic Genotype 1 HCV and HIV Co-infection","status":"COMPLETED","sponsor":"Taoyuan General Hospital","startDate":"2017-10-20","conditions":["Chronic Hepatitis C"],"enrollment":40,"completionDate":"2018-11-30"},{"nctId":"NCT02358044","phase":"PHASE3","title":"Efficacy and Safety of Combination Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Sofosbuvir + Pegylated Interferon + Ribavirin in Hepatitis C Virus Genotype 1, 4 or 6 Infection (MK-5172-077)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2015-02-27","conditions":["Hepatitis C"],"enrollment":257,"completionDate":"2016-02-16"},{"nctId":"NCT02252016","phase":"PHASE3","title":"Grazoprevir (MK-5172) and Elbasvir (MK-8742) Combination for Chronic Hepatitis C Virus (HCV) Genotypes 1, 4, and 6 (MK-5172-065)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-10-22","conditions":["Hepatitis C"],"enrollment":159,"completionDate":"2016-06-14"},{"nctId":"NCT02105467","phase":"PHASE3","title":"Study of Efficacy and Safety of Grazoprevir (MK-5172)/Elbasvir (MK-8742) Combination Regimen for Treatment-Naïve Participants With Chronic Hepatitis C Virus Genotypes 1, 4, and 6 (MK-5172-060)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-06-05","conditions":["Chronic Hepatitis C Virus"],"enrollment":421,"completionDate":"2015-09-06"},{"nctId":"NCT02105454","phase":"PHASE2","title":"Study of Grazoprevir (MK-5172) + Elbasvir (MK-8742) + Ribavirin in Participants With Chronic Hepatitis C Who Failed Prior Direct-Acting Antiviral Therapy (MK-5172-048)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-05-23","conditions":["Hepatitis C Virus"],"enrollment":79,"completionDate":"2015-05-04"},{"nctId":"NCT02092350","phase":"PHASE2,PHASE3","title":"Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic Kidney Disease (MK-5172-052)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-03-17","conditions":["Hepatitis C Virus"],"enrollment":237,"completionDate":"2015-09-02"},{"nctId":"NCT01716156","phase":"PHASE2","title":"A Study of Different Durations of Treatment With Grazoprevir (MK-5172) in Combination With Ribavirin in Participants With Chronic Hepatitis C (MK-5172-039)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2013-01-18","conditions":["Hepatitis C"],"enrollment":26,"completionDate":"2014-03-12"},{"nctId":"NCT02203149","phase":"PHASE2,PHASE3","title":"Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-08-01","conditions":["Hepatitis C"],"enrollment":399,"completionDate":"2016-05-16"},{"nctId":"NCT01390428","phase":"PHASE1","title":"Study to Investigate the Influence of Hepatic Insufficiency on the Pharmacokinetics of Grazoprevir (MK-5172-013)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2011-07-28","conditions":["Hepatitis C"],"enrollment":50,"completionDate":"2014-09-12"},{"nctId":"NCT01537900","phase":"PHASE1","title":"A Multiple Dose Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Participants (MK-5172-010)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2013-10-01","conditions":["Hepatitis C"],"enrollment":4,"completionDate":"2014-07-31"},{"nctId":"NCT02781649","phase":"PHASE4","title":"Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients","status":"COMPLETED","sponsor":"Johns Hopkins University","startDate":"2016-07-20","conditions":["End-Stage Renal Disease","Hepatitis C"],"enrollment":10,"completionDate":"2018-01-01"},{"nctId":"NCT02785666","phase":"PHASE3","title":"Swiss HCVree Trial","status":"COMPLETED","sponsor":"University of Zurich","startDate":"2016-06","conditions":["Hepatitis C","HIV"],"enrollment":150,"completionDate":"2018-08"},{"nctId":"NCT03585101","phase":"PHASE4","title":"A Single-arm Evaluation of the Effect of HCV Treatment on Cardiovascular Disease Risk","status":"WITHDRAWN","sponsor":"University of California, Los Angeles","startDate":"2018-08","conditions":["Hepatitis C"],"enrollment":0,"completionDate":"2020-04"},{"nctId":"NCT00998985","phase":"PHASE1","title":"A Study of Grazoprevir (MK-5172) in Hepatitis C-Infected Male Participants (MK-5172-004)","status":"COMPLETED","sponsor":"Merck Sharp & Dohme LLC","startDate":"2010-02-23","conditions":["Hepatitis C"],"enrollment":91,"completionDate":"2012-11-08"},{"nctId":"NCT03105349","phase":"PHASE4","title":"A Clinical Trial of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotypes 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A","status":"WITHDRAWN","sponsor":"Fundacion SEIMC-GESIDA","startDate":"2017-07-01","conditions":["HCV"],"enrollment":0,"completionDate":"2018-02"},{"nctId":"NCT03407703","phase":"","title":"Hepatitis C (HCV) Cure and Kidney Health","status":"UNKNOWN","sponsor":"San Francisco Veterans Affairs Medical Center","startDate":"2018-03-27","conditions":["Hepatitis C"],"enrollment":50,"completionDate":"2019-12-31"},{"nctId":"NCT03145623","phase":"","title":"Retrospective Efficacy and Safety Study With Elbasvir/Grazoprevir in HCV-infected Patients With Chronic Kidney Disease","status":"COMPLETED","sponsor":"University Hospital, Toulouse","startDate":"2017-06-02","conditions":["Hepatitis C","Chronic Kidney Diseases"],"enrollment":100,"completionDate":"2017-12-31"},{"nctId":"NCT03433326","phase":"","title":"Grazoprevir and Elbasvir Without Ribavirin for 12 Weeks in Patients With HCV-related Cryoglobulinemic Nephropathy","status":"UNKNOWN","sponsor":"University of Florence","startDate":"2018-03-01","conditions":["Hepatitis C","Cryoglobulinaemic Glomerulonephritis"],"enrollment":45,"completionDate":"2018-12-31"},{"nctId":"NCT03359746","phase":"PHASE4","title":"Grazoprevir/Elbasvir for Treatment of Hepatitis C Virus Genotype 4 Post Kidney Transplant","status":"UNKNOWN","sponsor":"King Faisal Specialist Hospital & Research Center","startDate":"2017-12-15","conditions":["Hepatitis C"],"enrollment":40,"completionDate":"2018-12-31"},{"nctId":"NCT03143998","phase":"PHASE4","title":"Efficacy and Safety of Elbasvir/Grazoprevir in Brazilian Participants With Chronic Hepatitis C Virus (HCV) Genotype 1 Infection With Advanced Fibrosis (F3 and F4)","status":"WITHDRAWN","sponsor":"Merck Sharp & Dohme LLC","startDate":"2018-02-12","conditions":["Hepatitis C"],"enrollment":0,"completionDate":"2019-01-12"},{"nctId":"NCT03222167","phase":"PHASE3","title":"Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b","status":"UNKNOWN","sponsor":"Institute Of Cardiology & Internal Diseases, Kazakhstan","startDate":"2017-10","conditions":["Chronic Hepatitis C Genotype 1B","Metabolic Syndrome","Fibrosis, Liver","Cirrhoses, Liver"],"enrollment":60,"completionDate":"2019-08"},{"nctId":"NCT02647632","phase":"PHASE2","title":"Study to Assess Efficacy and Safety of Grazoprevir/Elbasvir Associated With Sofosbuvir and Ribavirin in HCV Genotype 1 or 4-infected Patients Who Failed Direct Acting Antivirals (DAA) Bitherapy With Sofosbuvir","status":"COMPLETED","sponsor":"ANRS, Emerging Infectious Diseases","startDate":"2016-01","conditions":["Hepatitis C"],"enrollment":26,"completionDate":"2017-04"},{"nctId":"NCT03110055","phase":"NA","title":"the Effect of Grazoprevir/Elbasvir and TACE vs. TACE Alone in Prolonging Survival of Patients With Non-resectable HCV Associated HCC.","status":"UNKNOWN","sponsor":"Tel-Aviv Sourasky Medical Center","startDate":"2017-05-01","conditions":["HCV, HCC"],"enrollment":20,"completionDate":"2019-05-01"},{"nctId":"NCT03022006","phase":"PHASE4","title":"Safety and Effect of Elbasvir/Grazoprevir Combination Therapy in Hemodialysis Patients With Chronic Hepatitis C","status":"UNKNOWN","sponsor":"Norte Study Group","startDate":"2017-01-15","conditions":["Chronic Hepatitis C"],"enrollment":60,"completionDate":""},{"nctId":"NCT02057003","phase":"","title":"Real-life Security and Efficacy of DAA-based Therapy in HCV/HIV-Coinfected Patients","status":"UNKNOWN","sponsor":"Valme University Hospital","startDate":"2012-01","conditions":["Hepatitis C, Chronic","Human Immunodeficiency Virus"],"enrollment":1000,"completionDate":"2020-12"},{"nctId":"NCT02732405","phase":"PHASE3","title":"Study to Investigate Tolerability and Efficacy of MK5172 / MK8742 Without Ribavirin for 12 Weeks in Patients With Chronic HCV G1b Infection With Compensated Cirrhosis","status":"UNKNOWN","sponsor":"Istituto Clinico Humanitas","startDate":"2016-05","conditions":["Hepatitis C","Compensated Cirrhosis"],"enrollment":120,"completionDate":"2017-03"},{"nctId":"NCT01547312","phase":"PHASE1","title":"Evaluation of Hepatic Pharmacokinetics for Grazoprevir (MK-5172) in Participants With Chronic Hepatitis C (MK-5172-022)","status":"WITHDRAWN","sponsor":"Merck Sharp & Dohme LLC","startDate":"2012-05","conditions":["Chronic Hepatitis C"],"enrollment":0,"completionDate":"2012-11"},{"nctId":"NCT02204475","phase":"PHASE3","title":"Grazoprevir (MK-5172)/Elbasvir (MK-8742) Versus Boceprevir/Pegylated Interferon/Ribavarin for Chronic Hepatitis C Infection (MK-5172-066)","status":"WITHDRAWN","sponsor":"Merck Sharp & Dohme LLC","startDate":"2014-11","conditions":["Hepatitis C"],"enrollment":0,"completionDate":"2016-09"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"_patentsChecked":true,"crossReferences":{"MMSL":"31483","NDDF":"016674","UNII":"4O2AB118LA","CHEBI":"CHEBI:132975","VANDF":"4035374","RXNORM":"1734630","UMLSCUI":"C4080053","ChEMBL_ID":"CHEMBL3039533","KEGG_DRUG":"D10639","DRUGBANK_ID":"DB11575","PDB_CHEM_ID":"SUE","PUBCHEM_CID":"44603531","SNOMEDCT_US":"716041004","IUPHAR_LIGAND_ID":"11573","SECONDARY_CAS_RN":"1350462-55-3","MESH_SUPPLEMENTAL_RECORD_UI":"C578009"},"formularyStatus":[],"_enricherVersion":"v2","developmentCodes":[],"ownershipHistory":[{"period":"2016-","companyName":"Merck & Co.","relationship":"Original Developer"}],"pharmacokinetics":{"source":"DrugCentral","bioavailability":"16%"},"publicationCount":427,"therapeuticAreas":["Infectious Disease"],"_revenueScrapedAt":"2026-03-31 10:54:48.131513+00","atcClassification":{"source":"DrugCentral","atcCode":"J05AP11","allCodes":["J05AP11","J05AP54"]},"biosimilarFilings":[],"originalDeveloper":"Merck Sharp Dohme","recentPublications":[],"companionDiagnostics":[],"genericManufacturerList":[],"status":"discontinued","companyName":"Merck & Co.","companyId":"merck","modality":"Small molecule","firstApprovalDate":"2016","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"US","regulator":"FDA","status":"approved","approval_date":"2016-01-28T00:00:00.000Z","mah":"MERCK SHARP DOHME","brand_name_local":null,"application_number":""},{"country_code":"IL","regulator":"MOH","status":"likely_approved","approval_date":"2016-01-28T00:00:00.000Z","mah":"MERCK SHARP DOHME","brand_name_local":null,"application_number":null},{"country_code":"SG","regulator":"HSA","status":"likely_approved","approval_date":"2016-01-28T00:00:00.000Z","mah":"MERCK SHARP DOHME","brand_name_local":null,"application_number":null},{"country_code":"SA","regulator":"SFDA","status":"likely_approved","approval_date":"2016-01-28T00:00:00.000Z","mah":"MERCK SHARP DOHME","brand_name_local":null,"application_number":null},{"country_code":"AE","regulator":"MOH","status":"likely_approved","approval_date":"2016-01-28T00:00:00.000Z","mah":"MERCK SHARP DOHME","brand_name_local":null,"application_number":null},{"country_code":"KR","regulator":"MFDS","status":"likely_approved","approval_date":"2016-01-28T00:00:00.000Z","mah":"MERCK SHARP DOHME","brand_name_local":null,"application_number":null},{"country_code":"CA","regulator":"Health Canada","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"AU","regulator":"TGA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null},{"country_code":"GB","regulator":"MHRA","status":"likely_approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"patentsNormalised":[{"patent_number":"7973040","territory":"US","patent_type":null,"expiry_date":"2029-07-24T00:00:00.000Z","status":"active","paragraph_iv_filed":false},{"patent_number":"8871759","territory":"US","patent_type":null,"expiry_date":"2031-05-04T00:00:00.000Z","status":"active","paragraph_iv_filed":false}],"trialStats":{"total":6,"withResults":3},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}