Study of the Anti-HCV Drug (BMS-790052) Combined With Peginterferon and Ribavirin in Patients Who Failed Prior Treatment
| Status: | Completed |
|---|---|
| Conditions: | Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/21/2016 |
| Start Date: | August 2010 |
| End Date: | December 2012 |
A Phase 2B Study of BMS-790052 in Combination With Peginterferon Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Infected Subjects Who Are Null or Partial Responders to Prior Treatment With Peginterferon Alfa Plus Ribavirin Therapy
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.
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.
Inclusion Criteria:
- Subjects chronically infected with HCV genotype 1
- Non-responder to prior therapy with peginterferon alfa and ribavirin
- HCV RNA viral load of 100,00 IU/mL
- Results of a liver biopsy ≤ 24 months prior to randomization consistent with chronic
HCV infection; for compensated cirrhotics can be any time prior to randomization
(compensated cirrhotics biopsy enrollment will be capped at 25% of randomized study
population)
- Ultrasound, CT scan or MRI results 12 months prior to randomization that do not
demonstrate hepatocellular carcinoma
- Body Mass Index (BMI) of 18 to 35 kg/m2
Exclusion Criteria:
- Positive for Hepatitis B infection (HBsAg) or 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
36
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University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Miami Research Associates Miami Research Associates (MRA) is the largest privately-owned multi-specialty clinical research center...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
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Yale University School of Medicine Founded in 1810, the Yale School of Medicine is a...
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Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
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California Pacific Medical Center California Pacific Medical Center is one of the largest private, not-for-profit,...
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Saint Louis University Saint Louis University is a Catholic, Jesuit institution with campuses in St....
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