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NCT01359644 · ClinicalTrials.gov registry record · Phase 2
Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 350
- Enrollment target
NCT01359644: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01359644 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 350 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (163% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01359644, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 350 participants
- Enrollment target
Study Summary
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment
Primary Outcome
SVR12 was defined as hepatitis C virus (HCV) RNA less than the lower limit of quantitation, target detected or target not detected (ie, HCV RNA \<25 IU/mL) at follow-up Week 12. DCV=daclatasvir, SOF=sofosbuvir.
Interventions
- DRUG Ribavirin
- DRUG Daclatasvir
- DRUG PSI-7977
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 350 participants |
| Start Date | 2011-06 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT01359644 record still lists
NCT01359644 is an interventional study that assigns participants to a tested intervention. The registered 350 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (163% higher).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT01359644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01359644 about?
NCT01359644 is a clinical study titled "Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care". The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV ...
What is the current status of trial NCT01359644?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 350 participants. The study started on 2011-06. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01359644?
The interventions under investigation include: Ribavirin (DRUG), Daclatasvir (DRUG), PSI-7977 (DRUG).
Who is sponsoring clinical trial NCT01359644?
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 NCT01359644's enrollment target sits among peer trials
350 130th of 2000 higher than 1,865 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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