NCT02203149 is a Phase 2, PHASE3 clinical trial of Grazoprevir in Hepatitis C, sponsored by Merck Sharp & Dohme LLC.

Who is sponsoring NCT02203149?

NCT02203149 is sponsored by Merck Sharp & Dohme LLC.

What drugs are being tested in NCT02203149?

Interventions in NCT02203149: Grazoprevir, Elbasvir, Placebo to Grazoprevir, Placebo to Elbasvir.

What condition does NCT02203149 study?

NCT02203149 studies Hepatitis C.

Is NCT02203149 still recruiting?

NCT02203149 is currently completed. Last updated 24 September 2018.

Are results published for NCT02203149?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-09-24 · How we verify

NCT02203149

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Study of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Japanese Participants With Chronic Hepatitis C (MK-5172-058)

Completed Phase 2, PHASE3 Results posted Last updated 24 September 2018

What this trial tests

Phase 2, PHASE3 trial testing Grazoprevir in Hepatitis C in 399 participants. Completed in 16 May 2016.

Timeline

1 August 2014

Primary endpoint
2 October 2015

16 May 2016

Quick facts

Lead sponsor	Merck Sharp & Dohme LLC
Phase	Phase 2, PHASE3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	399
Start date	1 August 2014
Primary completion	2 October 2015
Estimated completion	16 May 2016

Drugs / interventions tested

Grazoprevir (GRAZOPREVIR) — full drug profile →
Elbasvir (ELBASVIR) — full drug profile →
Placebo to Grazoprevir — full drug profile →
Placebo to Elbasvir — full drug profile →

Conditions studied

Hepatitis C — all drugs for Hepatitis C →

Sponsor

Merck Sharp & Dohme LLC — full company profile →

Who can join

Adults 20 to 80, any sex, with Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Part 2: Percentage of Treatment-naïve Participants in the Immediate Treatment Arm Achieving Sustained Viral Response at 12 Weeks After The End of All Treatment (SVR12) Primary · 12 weeks after end of all therapy in Part 2 (Study Week 24 of Part 2)

Blood was drawn from each participant to assess Hepatitis C Virus ribonucleic acid (HCV RNA) plasma levels using the Roche COBAS® Taqman quantitative reverse transcription-polymerase chain reaction (RT-PCR) assay, v2.0, which had a lower limit of quantification (LLoQ) of 1.2 Log IU/mL (15 IU/mL) and a lower limit of detection (LLoD) below 15 IU/ml (no specific value). SVR12 was defined as undetectable HCV RNA (target not detected) at 12 weeks after the end of all study therapy. The Clopper-Pearson method was used to construct 95% confidence intervals (CIs) for the SVR12 rate. The lower limit o

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	96.6	92.3 – 98.9

Part 1: Percentage of Participants Experiencing an Adverse Event (AE) During Treatment and First 4 Follow-Up Weeks Primary · Up to 4 weeks post last dose in Part 1 (Up to total of 16 weeks)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that is temporally

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	67.7
Part 1 Grazoprevir 100 mg + Elbasvir	74.2

Part 1: Percentage of Participants That Discontinued Treatment Due to an AE Primary · Up to Study Week 12 in Part 1

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	0.0
Part 1 Grazoprevir 100 mg + Elbasvir	0.0

Part 1: Percentage of Participants Achieving Undetectable HCV RNA Over Time Secondary · Part 1 Treatment Weeks (TW)2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.

TW2

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	22.6	9.6 – 41.1
Part 1 Grazoprevir 100 mg + Elbasvir	35.5	19.2 – 54.6

TW4

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	77.4	58.9 – 90.4
Part 1 Grazoprevir 100 mg + Elbasvir	83.9	66.3 – 94.5

TW12

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	100.0	88.8 – 100.0
Part 1 Grazoprevir 100 mg + Elbasvir	100.0	88.8 – 100.0

EOT

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	100.0	88.8 – 100.0
Part 1 Grazoprevir 100 mg + Elbasvir	100.0	88.8 – 100.0

FUWK4

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	100.0	88.8 – 100.0
Part 1 Grazoprevir 100 mg + Elbasvir	100.0	88.8 – 100.0

FUWK12

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	100.0	88.8 – 100.0
Part 1 Grazoprevir 100 mg + Elbasvir	96.8	83.3 – 99.9

FUWK24

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	96.8	83.3 – 99.9
Part 1 Grazoprevir 100 mg + Elbasvir	96.8	83.3 – 99.9

Part 1: Percentage of Participants Achieving HCV RNA Below the Lower Limit of Quantitation (<LLoQ) Over Time Secondary · Part 1 TW2, TW4, TW12, EOT, FUWK4, FUWK12, FUWK24

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA \<LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. The Clopper-Pearson method was used to construct 95% CIs for SVR rates.

TW2

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	61.3	42.2 – 78.2
Part 1 Grazoprevir 100 mg + Elbasvir	71.0	52.0 – 85.8

TW4

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	100.0	88.8 – 100.0
Part 1 Grazoprevir 100 mg + Elbasvir	100.0	88.8 – 100.0

TW12

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	100.0	88.8 – 100.0
Part 1 Grazoprevir 100 mg + Elbasvir	100.0	88.8 – 100.0

EOT

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	100.0	88.8 – 100.0
Part 1 Grazoprevir 100 mg + Elbasvir	100.0	88.8 – 100.0

FUWK4

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	100.0	88.8 – 100.0
Part 1 Grazoprevir 100 mg + Elbasvir	100.0	88.8 – 100.0

FUWK12

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	100.0	88.8 – 100.0
Part 1 Grazoprevir 100 mg + Elbasvir	96.8	83.3 – 99.9

FUWK24

Group	Value	95% CI
Part 1 Grazoprevir 50 mg + Elbasvir	100.0	88.8 – 100.0
Part 1 Grazoprevir 100 mg + Elbasvir	96.8	83.3 – 99.9

Part 2: Percentage of Participants Experiencing an AE During Initial Treatment and First 4 Follow-Up Weeks Primary · Up to 4 weeks following initial treatment in Part 2 (Up to total of 16 weeks)

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary sa

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	64.8
Part 2 Non-cirrhotic Deferred: Placebo	67.6
Part 2 Cirrhotic: Grazoprevir + Elbasvir	80.0

Part 2: Percentage of Participants That Discontinued Initial Treatment Due to an AE Primary · Up to Study Week 12 in Part 2

An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening of a preexisting condition that is temporally associated with the use of the Sponsor's product, was also an AE. The primary sa

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	1.3
Part 2 Non-cirrhotic Deferred: Placebo	1.4
Part 2 Cirrhotic: Grazoprevir + Elbasvir	0.0

Part 2: Percentage of Participants Achieving Undetectable HCV RNA Over Time After Active Treatment Secondary · Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with undetectable HCV RNA at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to constru

TW2

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	25.1	19.6 – 31.3
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	39.7	28.5 – 51.9
Part 2 Cirrhotic: Grazoprevir + Elbasvir	11.4	3.2 – 26.7

TW4

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	70.5	64.1 – 76.3
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	86.3	76.2 – 93.2
Part 2 Cirrhotic: Grazoprevir + Elbasvir	65.7	47.8 – 80.9

TW12

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	97.8	94.9 – 99.3
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	100.0	95.1 – 100.0
Part 2 Cirrhotic: Grazoprevir + Elbasvir	100.0	90.0 – 100.0

EOT

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	98.7	96.2 – 99.7
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	100.0	95.1 – 100.0
Part 2 Cirrhotic: Grazoprevir + Elbasvir	100.0	90.0 – 100.0

FUWK4

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	98.2	95.5 – 99.5
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	100.0	95.1 – 100.0
Part 2 Cirrhotic: Grazoprevir + Elbasvir	97.1	85.1 – 99.9

FUWK12

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	96.5	93.2 – 98.5
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	95.9	88.5 – 99.1
Part 2 Cirrhotic: Grazoprevir + Elbasvir	97.1	85.1 – 99.9

FUWK24

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	96.5	93.2 – 98.5
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	95.9	88.5 – 99.1
Part 2 Cirrhotic: Grazoprevir + Elbasvir	94.3	80.8 – 99.3

Part 2: Percentage of Participants Achieving HCV RNA <LLoQ Over Time After Active Treatment Secondary · Part 2: Active TW2, TW4, TW12, End of Treatment (EOT), FUWK4, FUWK12, FUWK24

Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0, which had a LLoQ of 1.2 Log IU/mL (15 IU/mL) and a LLoD below 15 IU/ml (no specific value). Undetectable HCV RNA was defined as HCV RNA target not detected. The percentage of participants with HCV RNA \<LLoQ at TW2, TW4, TW12, EOT, FUWK4, FUWK12, and FUWK24 is summarized for each arm. Data reported for the Part 2 Deferred Treatment Arm corresponds to the deferred active treatment weeks and subsequent follow-up. The Clopper-Pearson method was used to construct 95%

TW2

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	60.8	54.1 – 67.2
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	69.9	58.0 – 80.1
Part 2 Cirrhotic: Grazoprevir + Elbasvir	60.0	42.1 – 76.1

TW4

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	96.0	92.6 – 98.2
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	98.6	92.6 – 100.0
Part 2 Cirrhotic: Grazoprevir + Elbasvir	94.3	80.8 – 99.3

TW12

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	98.7	96.2 – 99.7
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	100.0	95.1 – 100.0
Part 2 Cirrhotic: Grazoprevir + Elbasvir	100.0	90.0 – 100.0

EOT

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	99.6	97.6 – 100.0
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	100.0	95.1 – 100.0
Part 2 Cirrhotic: Grazoprevir + Elbasvir	100.0	90.0 – 100.0

FUWK4

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	98.2	95.5 – 99.5
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	100.0	95.1 – 100.0
Part 2 Cirrhotic: Grazoprevir + Elbasvir	97.1	85.1 – 99.9

FUWK12

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	96.5	93.2 – 98.5
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	97.3	90.5 – 99.7
Part 2 Cirrhotic: Grazoprevir + Elbasvir	97.1	85.1 – 99.9

FUWK24

Group	Value	95% CI
Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir	96.5	93.2 – 98.5
Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir	95.9	88.5 – 99.1
Part 2 Cirrhotic: Grazoprevir + Elbasvir	97.1	85.1 – 99.9

Adverse events — posted to ClinicalTrials.gov

Time frame: Part 1: Up to a total of 36 weeks Part 2: Up to a total of 52 weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Part 1 Grazoprevir 50 mg + Elbasvir

Serious: 2/31 (6%)

Deaths: —

Part 1 Grazoprevir 100 mg + Elbasvir

Serious: 1/31 (3%)

Deaths: —

Part 2 Non-cirrhotic Immediate: Grazoprevir + Elbasvir

Serious: 19/227 (8%)

Deaths: —

Part 2 Non-cirrhotic Deferred: Placebo

Serious: 1/74 (1%)

Deaths: —

Part 2 Non-cirrhotic Deferred: Grazoprevir + Elbasvir

Serious: 2/73 (3%)

Deaths: —

Part 2 Cirrhotic: Grazoprevir + Elbasvir

Serious: 3/35 (9%)

Deaths: —

Serious adverse events (27 terms)

Reaction	System	Part 1 Grazoprevir 50 mg +…	Part 1 Grazoprevir 100 mg …	Part 2 Non-cirrhotic Immed…	Part 2 Non-cirrhotic Defer…	Part 2 Non-cirrhotic Defer…	Part 2 Cirrhotic: Grazopre…
Cataract	Eye disorders	—	—	—	—	—	—
Acute coronary syndrome	Cardiac disorders	—	—	—	—	—	—
Cardiac sarcoidosis	Cardiac disorders	—	—	—	—	—	—
Colitis ischaemic	Gastrointestinal disorders	—	—	—	—	—	—
Angina pectoris	Cardiac disorders	—	—	—	—	—	—
Haematochezia	Gastrointestinal disorders	—	—	—	—	—	—
Haemorrhagic erosive gastritis	Gastrointestinal disorders	—	—	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—	—	—
Inguinal hernia	Gastrointestinal disorders	—	—	—	—	—	—
Large intestine polyp	Gastrointestinal disorders	—	—	—	—	—	—
Appendicitis	Infections and infestations	—	—	—	—	—	—
Sinusitis	Infections and infestations	—	—	—	—	—	—
Tibia fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Arthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Osteoarthritis	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Benign anorectal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Colon cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Gastrointestinal tract adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	—	—	—	—	—	—
Cerebral infarction	Nervous system disorders	—	—	—	—	—	—
Sciatica	Nervous system disorders	—	—	—	—	—	—

Other adverse events (23 terms — click to expand)

Reaction	System	Part 1 Grazoprevir 50 mg +…	Part 1 Grazoprevir 100 mg …	Part 2 Non-cirrhotic Immed…	Part 2 Non-cirrhotic Defer…	Part 2 Non-cirrhotic Defer…	Part 2 Cirrhotic: Grazopre…
Nasopharyngitis	Infections and infestations	—	—	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—	—	—
Alanine aminotransferase increased	Investigations	—	—	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—	—	—
Headache	Nervous system disorders	—	—	—	—	—	—
Aspartate aminotransferase increased	Investigations	—	—	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—	—	—
Cystitis	Infections and infestations	—	—	—	—	—	—
Arthralgia	Musculoskeletal and connective tissue disorders	—	—	—	—	—	—
Malaise	General disorders	—	—	—	—	—	—
Blood creatine phosphokinase increased	Investigations	—	—	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—	—	—
Accidental overdose	Injury, poisoning and procedural complications	—	—	—	—	—	—
Conjunctival haemorrhage	Eye disorders	—	—	—	—	—	—
Pyrexia	General disorders	—	—	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—	—	—
Dry eye	Eye disorders	—	—	—	—	—	—
Stomatitis	Gastrointestinal disorders	—	—	—	—	—	—
Periodontitis	Infections and infestations	—	—	—	—	—	—
Ligament sprain	Injury, poisoning and procedural complications	—	—	—	—	—	—
Tooth fracture	Injury, poisoning and procedural complications	—	—	—	—	—	—
Protein urine present	Investigations	—	—	—	—	—	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—	—	—	—	—	—

Most-reported serious reactions: Cataract, Acute coronary syndrome, Cardiac sarcoidosis, Colitis ischaemic, Angina pectoris, Haematochezia, Haemorrhagic erosive gastritis, Ileus.

Data from ClinicalTrials.gov NCT02203149 adverse events section.

Sponsor's own description

This is a two-part study of grazoprevir (MK-5172) + elbasvir (MK-8742) in Japanese participants with chronic hepatitis C virus (HCV) genotype 1 (GT1). Part I is a dose-finding study; in Part II, participants will be randomly assigned to receive grazoprevir at the dose determined in Part I in combination with elbasvir. The primary study hypothesis is that the percentage of treatment-naïve participants in the Immediate Treatment Arm of Part II who achieve sustained viral response at 12 weeks after the end of all treatment (SVR12) will be greater than the reference rate of 75%. A separate study arm for cirrhotic participants will also be included in Part II; these participants will receive grazoprevir at the determined dose in combination with elbasvir.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

The combination of elbasvir and grazoprevir for the treatment of chronic HCV infection in Japanese patients: a randomized phase II/III study.
Kumada H, Suzuki Y, Karino Y, Chayama K, et al · · 2017 · cited 60× · PMID 27873094 · DOI 10.1007/s00535-016-1285-y
The safety and efficacy of elbasvir and grazoprevir in participants with hepatitis C virus genotype 1b infection.
Zeuzem S, Serfaty L, Vierling J, Cheng W, et al · · 2018 · cited 36× · PMID 29344726 · DOI 10.1007/s00535-018-1429-3
Elbasvir/grazoprevir in women with hepatitis C virus infection taking oral contraceptives or hormone replacement therapy.
Hézode C, Kwo P, Sperl J, Hwang P, et al · · 2019 · cited 2× · PMID 31819666 · DOI 10.2147/ijwh.s203022
Efficacy and Safety of Elbasvir/Grazoprevir in Hepatitis C Virus GT1- and GT4-Infected People Aged 65 Years or Older.
Flamm S, Peng CY, Shibolet O, Nahass R, et al · · 2019 · cited 2× · PMID 30891470 · DOI 10.1177/2333721418817398

Verify or expand the search:

Other trials of Grazoprevir

Trials testing the same drug.

NCT02601573 — Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) With and Without Ribavirin (RBV) in Cirrhotic Subjects With Chronic · Phase 2 · completed
NCT02332720 — Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) fo · Phase 2 · completed
NCT02332707 — Efficacy and Safety of Grazoprevir (MK-5172) and Uprifosbuvir (MK-3682) With Elbasvir (MK-8742) or Ruzasvir (MK-8408) fo · Phase 2 · completed
NCT02115321 — Study of Efficacy and Safety of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Chronic Hepatitis C Participants With Chil · Phase 2, PHASE3 · completed
NCT02092350 — Safety and Efficacy of Grazoprevir (MK-5172) + Elbasvir (MK-8742) in Participants With Chronic Hepatitis C and Chronic K · Phase 2, PHASE3 · completed

Other recruiting trials for Hepatitis C

Currently open trials in the same condition.

NCT06263829 — HCV Tappt Adherence Study · NA · recruiting
NCT06179498 — Partner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs · NA · recruiting
NCT06367465 — Feasibility and Acceptability of HCV Treatment in Pregnancy · recruiting
NCT05668780 — Buprenorphine Integration Research and Community Health · NA · active not recruiting
NCT05208697 — Tele-Harm Reduction · NA · active not recruiting

Other Merck Sharp & Dohme LLC trials

Trials by the same sponsor.

NCT07224477 — A Clinical Study of V540A in Healthy Female Participants (V540A-005) · Phase 2 · not yet recruiting
NCT07302347 — A Study of Pembrolizumab in Japanese Pediatric Participants With Solid Tumors or Lymphomas and Japanese Adult Participan · Phase 1, PHASE2 · recruiting
NCT07528508 — A Clinical Trial in Healthy Participants to Study the Effect of a Single Dose of MK-8527 on Levels of Methadone (MK-8527 · Phase 1 · not yet recruiting
NCT07513376 — A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (M · Phase 3 · not yet recruiting
NCT07532304 — A Clinical Trial of MK-4646 With Bictegravir/Emtricitabine/Tenofovir Alafenamide and Dolutegravir in Healthy Adult Parti · Phase 1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02203149 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Merck Sharp & Dohme LLC
Last refreshed: 24 September 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02203149.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT02203149

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (27 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Grazoprevir

Other recruiting trials for Hepatitis C

Other Merck Sharp & Dohme LLC trials

Verify against primary sources