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NCT02032875 · ClinicalTrials.gov registry record · Phase 3
Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 116
- Enrollment target
NCT02032875: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT02032875 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 116 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02032875, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 116 participants
- Enrollment target
Study Summary
This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment. Under certain conditions, the treatment duration could have been extended for cirrhotic participants. The study tested the efficacy and safety of this combination for treatment of HCV in cirrhotic and post transplant patients.
Primary Outcome
SVR12 was defined as hepatitis C Virus (HCV) RNA levels below the lower limit of quantitation (\<LLOQ) i.e., 25 IU/mL target detected or target not detected, at post-treatment Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. For participants who missed the follow-up Week 12 visit, SVR12 was imputed using the next and closest available HCV RNA measurement after the follow-up Week 12 window.
Interventions
- DRUG Ribavirin
- DRUG Sofosbuvir
- DRUG Daclatasvir
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 116 participants |
| Start Date | 2014-03 |
| Est. Completion | 2016-01 |
| Phase | Phase 3 |
What the finished NCT02032875 record still lists
NCT02032875 is an interventional study that assigns participants to a tested intervention. The registered 116 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (85% lower).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT02032875 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02032875 about?
NCT02032875 is a clinical study titled "Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant". This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment. Under certain conditions, the treatment duration could have been extended for ci...
What is the current status of trial NCT02032875?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 116 participants. The study started on 2014-03. Estimated completion is 2016-01.
What interventions are being tested in trial NCT02032875?
The interventions under investigation include: Ribavirin (DRUG), Sofosbuvir (DRUG), Daclatasvir (DRUG).
Who is sponsoring clinical trial NCT02032875?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02032875's enrollment target sits among peer trials
116 1643rd of 2000 higher than 357 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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