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NCT02596880: SD100
Sustained Viral Response Rate in 100 Subjects With Cirrhosis Due to Hepatitis C Treated With 12 Weeks of Sofosbuvir, Daclatasvir and Ribavirin
Phase 3 trial testing Sofosbuvir in Hepatitis C in 100 participants. Completed in 1 June 2016.
1 April 2016
Quick facts
| Lead sponsor | Tehran University of Medical Sciences |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 September 2015 |
| Primary completion | 1 April 2016 |
| Estimated completion | 1 June 2016 |
| Sites | 1 location across Iran |
Drugs / interventions tested
- Sofosbuvir — full drug profile →
- Daclatasvir (DACLATASVIR) — full drug profile →
- Ribavirin — full drug profile →
Conditions studied
- Hepatitis C — all drugs for Hepatitis C →
- Cirrhosis — all drugs for Cirrhosis →
Sponsor
Tehran University of Medical Sciences
Who can join
Adults 18 to 75, any sex, with Hepatitis C or Cirrhosis. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
The sustained viral response rate
Time frame: week 24 (12 weeks after end of treatment)
Qualitative HCV RNA polymerase chain reaction (PCR)
Sponsor's own description
The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if \<75 kg, 1200 mg/d if \>75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT02596880
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Sofosbuvir
Trials testing the same drug.
- NCT05717400 — Improving Response to Immunotherapy in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C Virus Inf · Phase 4 · terminated
- NCT04497649 — Sofosbuvir Containing Regimens in Treatment of COVID 19 Patients · Phase 2, PHASE3 · unknown
- NCT04246723 — Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chr · Phase 2 · completed
- NCT04111367 — Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 2,3,6 Hepatitis C Virus Infection Patients · Phase 2 · unknown
- NCT03883698 — Safety of Sofosbuvir in People With Advanced Kidney Failure · Phase 3 · completed
Other recruiting trials for Hepatitis C
Currently open trials in the same condition.
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- 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 Tehran University of Medical Sciences trials
Trials by the same sponsor.
- NCT07305883 — Comparison of Intranasal Ketorolac and Intranasal Ketamine in Digital Nerve Block Pain · Phase 3 · not yet recruiting
- NCT06876194 — The Effect of Music on the Sedation Quality Among Children in the Emergency Department. · Phase 3 · completed
- NCT06721273 — Iodine Supplementation and Fertility Parameters · NA · not yet recruiting
- NCT07014397 — Effect of Valaciclovir on Inter-Appointment Pain in Endodontic Treatment of Necrotic Teeth · NA · completed
- NCT06615934 — Effects of Aerobic and Resistance Exercises on Inpatients Liver Transplantation Recipients · NA · 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)
- Trial protocol + status: ClinicalTrials.gov NCT02596880 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tehran University of Medical Sciences
- Last refreshed: 18 April 2023
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/NCT02596880.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing