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NCT01170962 · ClinicalTrials.gov registry record · Phase 2
Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
A Phase 2 study of Hepatitis C Virus, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 2
- Development phase
- 512
- Enrollment target
- 20
- Study locations
NCT01170962: Completed Phase 2 study of Hepatitis C Virus, sponsored by Bristol-Myers Squibb.
NCT01170962 is a Phase 2 study of Hepatitis C Virus that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 512 participants, above the 147-participant average among 3 other Hepatitis C Virus trials with a reported enrollment target (248% higher). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01170962, a Phase 2 study of Hepatitis C Virus, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 512 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
Primary Outcome
eRVR was defined as undetectable Hepatitis C virus RNA at both Weeks 4 and 12. HCV RNA levels were measured by the Roche COBAS® TaqMan® HCV Test version 2.0 from the central laboratory.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG BMS-790052
- DRUG peginterferon alfa-2a
- DRUG ribavirin
Study Locations (20)
California
- Scripps Clinic - La Jolla
- CLI - Los Angeles
- Desta Digestive Disease Medical Center - San Diego
- University Of California At San Francisco - San Francisco
- California Pacific Medical Center - San Francisco
- Kaiser Permanente Medical Center - San Francisco
Maryland
- Mercy Medical Center - Baltimore
- Digestive Disease Associates, P.A. - Baltimore
- Johns Hopkins Medical Institutions - Lutherville
Florida
- University Of Florida Hepatology - Gainesville
- Miami Research Associates - South Miami
New York
- Samuel S. Stratton Vamc - Albany
- James Sungsik Park, M.D. C.N.S.C. - Great Neck
Alabama
- Alabama Liver & Digestive Specialists (Alds) - Montgomery
Colorado
- Transplant Center And Hepatology Clinic, B-154 - Aurora
Connecticut
- Yale University School Of Medicine - New Haven
Indiana
- Indiana University - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 512 participants |
| Start Date | 2010-08 |
| Est. Completion | 2012-12 |
| Phase | Phase 2 |
What the finished NCT01170962 record still lists
NCT01170962 is an interventional study that assigns participants to a tested intervention. The registered 512 participants enrollment target is mid-sized for trials with a published cap, above the 147-participant average among 3 other Hepatitis C Virus trials with a reported enrollment target (248% higher).
The record links to 1 condition, with Hepatitis C Virus appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01170962 names 20 study sites across 11 states, led by California, Maryland, Florida.
Frequently Asked Questions
What is clinical trial NCT01170962 about?
NCT01170962 is a clinical study titled "Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment". The purpose of this study is to determine whether BMS-790052 added to Peginterferon Alfa-2a and ribavirin can result in higher cure rates in patients who previously failed therapy and may have limited response to retreatment with Peginterferon Alfa-2a and ribavirin alone.
What is the current status of trial NCT01170962?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 512 participants. The study started on 2010-08. Estimated completion is 2012-12.
What conditions does trial NCT01170962 study?
This clinical trial studies the following conditions: Hepatitis C Virus.
What interventions are being tested in trial NCT01170962?
The interventions under investigation include: Placebo (DRUG), BMS-790052 (DRUG), peginterferon alfa-2a (DRUG), ribavirin (DRUG).
Who is sponsoring clinical trial NCT01170962?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01170962 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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