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NCT01448044 · ClinicalTrials.gov registry record · Phase 3
Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 152
- Enrollment target
NCT01448044: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.
NCT01448044 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 152 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01448044, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 152 participants
- Enrollment target
Study Summary
The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).
Primary Outcome
Participants were assessed for sustained virologic response 12 weeks post treatment (SVR12) defined as hepatitis C virus (HCV) RNA levels \< lower limit of quantitation (LLOQ was 25 IU/mL), target detected (TD) or target not detected (TND) at post-treatment Week 12.
Interventions
- DRUG Ribavirin
- DRUG BMS-790052 (NS5A Replication Complex Inhibitor)
- DRUG Placebo matching BMS-790052
- DRUG Pegylated-interferon alfa 2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 152 participants |
| Start Date | 2011-12 |
| Est. Completion | 2014-01 |
| Phase | Phase 3 |
What the finished NCT01448044 record still lists
NCT01448044 is an interventional study that assigns participants to a tested intervention. The registered 152 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 (80% lower).
The record links to 0 conditions, and to 4 interventions - of which Ribavirin is the first listed.
NCT01448044 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01448044 about?
NCT01448044 is a clinical study titled "Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C". The purpose of this study is to compare the sustained virologic response at post treatment Week 12 for each cohort (BMS-790052/Pegylated-interferon alfa 2a (pegIFNα-2a)/Ribavirin (RBV) versus placebo/PegIFNα-2a/RBV).
What is the current status of trial NCT01448044?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 152 participants. The study started on 2011-12. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01448044?
The interventions under investigation include: Ribavirin (DRUG), BMS-790052 (NS5A Replication Complex Inhibitor) (DRUG), Placebo matching BMS-790052 (DRUG), Pegylated-interferon alfa 2a (DRUG).
Who is sponsoring clinical trial NCT01448044?
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 NCT01448044's enrollment target sits among peer trials
152 1513th of 2000 higher than 484 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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