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NCT01125189 · ClinicalTrials.gov registry record · Phase 2
Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
A Phase 2 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 558
- Enrollment target
NCT01125189: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.
NCT01125189 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 558 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (320% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01125189, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 558 participants
- Enrollment target
Study Summary
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.
Primary Outcome
eRVR was defined as HCV RNA \<lower limit of quantitation and target not detected at both Weeks 4 and 12 on treatment.
Interventions
- DRUG Placebo
- DRUG Daclatasvir
- DRUG ribavirin
- DRUG peg-interferon alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2010-07 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT01125189 record still lists
NCT01125189 is an interventional study that assigns participants to a tested intervention. The registered 558 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 (320% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01125189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01125189 about?
NCT01125189 is a clinical study titled "Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients". To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.
What is the current status of trial NCT01125189?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 558 participants. The study started on 2010-07. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01125189?
The interventions under investigation include: Placebo (DRUG), Daclatasvir (DRUG), ribavirin (DRUG), peg-interferon alfa-2a (DRUG).
Who is sponsoring clinical trial NCT01125189?
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 NCT01125189's enrollment target sits among peer trials
558 60th of 2000 higher than 1,941 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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