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NCT01471574 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 549
- Enrollment target
NCT01471574: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01471574 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 549 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (29% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01471574, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 549 participants
- Enrollment target
Study Summary
The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV
Primary Outcome
SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory. HAART=highly active antiretroviral therapy. SVR12 was defined as hepatitis C virus (HCV) values lower than the lower limit of quantitation, target detected or target not detected at follow-up Week 12. HCV RNA levels were measured by the
Interventions
- DRUG Ribavirin
- DRUG Daclatasvir
- DRUG PEG-Interferon alfa 2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 549 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-09 |
| Phase | Phase 3 |
What the finished NCT01471574 record still lists
NCT01471574 is an interventional study that assigns participants to a tested intervention. The registered 549 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 (29% lower).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT01471574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01471574 about?
NCT01471574 is a clinical study titled "Safety and Efficacy Study of Daclatasvir (BMS-790052) Plus Pegylated Interferon-Alfa 2a and Ribavirin in Patients Coinfected With Untreated Hepatitis C Virus and HIV Virus". The purpose of this open label study is to evaluate the safety and efficacy of daclatasvir plus pegylated interferon-alfa 2a and ribavirin in untreated hepatitis C virus in patients coinfected with HIV
What is the current status of trial NCT01471574?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 549 participants. The study started on 2011-12. Estimated completion is 2014-09.
What interventions are being tested in trial NCT01471574?
The interventions under investigation include: Ribavirin (DRUG), Daclatasvir (DRUG), PEG-Interferon alfa 2a (DRUG).
Who is sponsoring clinical trial NCT01471574?
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 NCT01471574's enrollment target sits among peer trials
549 689th of 2000 higher than 1,312 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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