Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Participants in Some Hepatitis C Virus (HCV) Trials
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 5/3/2014 |
| Start Date: | October 2011 |
| End Date: | February 2017 |
| Contact: | For participation information at a USA site use a phone number below. For site information outside the USA please email: |
| Email: | Clinical.Trials@bms.com |
An Open-Label Re-Treatment Study With PegInterferon Alfa-2a, Ribavirin and BMS-790052 With or Without BMS-650032 for Subjects With Chronic Hepatitis C
The purpose of this study is to provide anti-HCV drugs to +/- 200 subjects treated in prior
BMS studies with placebo + Peginterferon Alfa-2a and Ribavirin and determine if the addition
of these drugs can result in higher cure rates in patients who previously failed therapy.
Approximately 100 genotype 1b subjects rolling over from BMS study AI447-028 who received
placebo will be treated with active drugs in this study.
BMS studies with placebo + Peginterferon Alfa-2a and Ribavirin and determine if the addition
of these drugs can result in higher cure rates in patients who previously failed therapy.
Approximately 100 genotype 1b subjects rolling over from BMS study AI447-028 who received
placebo will be treated with active drugs in this study.
- Intervention Model:
- Parallel: for all subjects entering the trial
- Cross-over: for genotype 1b subjects rolling over from AI447-028 who require
rescue therapy after initial treatment in this study
- Peginterferon Alfa-2a (pegIFNα-2a)
- Ribavirin (RBV)
- Daclatasvir (DCV)
- Asunaprevir (ASV)
- Parallel: for all subjects entering the trial
- Cross-over: for genotype 1b subjects rolling over from AI447-028 who require
rescue therapy after initial treatment in this study
- Peginterferon Alfa-2a (pegIFNα-2a)
- Ribavirin (RBV)
- Daclatasvir (DCV)
- Asunaprevir (ASV)
Inclusion Criteria:
- Prior participation in any BMS-790052, BMS-650032, BMS-791325 trial and assigned to
control arm (Peginterferon α/Ribavirin + Placebo) during the trial
- HCV genotype 1, 2, 3, or 4 (mixed genotypes are not permitted)
- HCV RNA viral load detectable
Exclusion Criteria:
- Discontinuation from prior BMS HCV clinical trial due to a
Peginterferon/Ribavirin-related event
- Any anti-HCV therapy following initial treatment with BMS-650032, BMS-790052 or
BMS-791325
- Positive for Hepatitis B infection (Hepatitis B surface antigen (HBsAg)) or Human
immunodeficiency virus 1 (HIV-1)/HIV-2 antibody at screening
- Evidence of medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
We found this trial at
20
sites
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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University of Miami A private research university with more than 15,000 students from around the...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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Yale-New Haven Hospital Relying on the skill and expertise of more than 4,500 university and...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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