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NCT01309932 · ClinicalTrials.gov registry record · Phase 2
Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin
A Phase 2 study of Hepatitis C, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 165
- Enrollment target
- 20
- Study locations
NCT01309932: Completed Phase 2 study of Hepatitis C, sponsored by Bristol-Myers Squibb.
NCT01309932 is a Phase 2 study of Hepatitis C that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 165 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01309932, a Phase 2 study of Hepatitis C, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 165 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.
Conditions Studied
Interventions
- BIOLOGICAL Pegylated Interferon Lambda (pegIFNλ)
- DRUG BMS-790052 (NS5A Inhibitor)
- DRUG Ribavirin (RBV)
- DRUG BMS-650032 (NS3 Protease Inhibitor)
- BIOLOGICAL Pegylated Interferon Alfa-2a (pegIFNα-2a)
Study Locations (20)
Other
- Local Institution - Clichy
- Local Institution - Créteil
- Local Institution - Montpellier
North Carolina
- Carolinas Medical Center - Charlotte
- Carolinas Center For Liver Disease - Statesville
Texas
- St. Luke'S Episcopal Hospital - Baylor College Of Medicine - Houston
- Texas Liver Institute - San Antonio
Victoria
- Local Institution - Clayton Vic
- Local Institution - Heidelberg
Arizona
- Mayo Clinic Hospital - Phoenix
California
- Desert Medical Group Inc. - Palm Springs
Colorado
- University Of Colorado Denver And Hospital - Aurora
Connecticut
- Yale University School Of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2011-03 |
| Est. Completion | 2014-09 |
| Phase | Phase 2 |
What the finished NCT01309932 record still lists
NCT01309932 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 5 interventions - of which Pegylated Interferon Lambda (pegIFNλ) is the first listed.
NCT01309932 names 20 study sites across 15 states, led by Other, North Carolina, Texas.
Frequently Asked Questions
What is clinical trial NCT01309932 about?
NCT01309932 is a clinical study titled "Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin". The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standa...
What is the current status of trial NCT01309932?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2011-03. Estimated completion is 2014-09.
What conditions does trial NCT01309932 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT01309932?
The interventions under investigation include: Pegylated Interferon Lambda (pegIFNλ) (BIOLOGICAL), BMS-790052 (NS5A Inhibitor) (DRUG), Ribavirin (RBV) (DRUG), BMS-650032 (NS3 Protease Inhibitor) (DRUG), Pegylated Interferon Alfa-2a (pegIFNα-2a) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01309932?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01309932 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01309932's enrollment target sits among peer trials
165 45th of 106 higher than 61 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C 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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Sofosbuvir (GS-7977) in Combination With PEG and Ribavirin for 12 Weeks in Treatment Experienced Subjects With Chronic HCV Infection Genotype 2 or 3
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