Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
Status: | Completed |
---|---|
Conditions: | Hepatitis, Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 4/21/2016 |
Start Date: | July 2010 |
End Date: | August 2012 |
A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection
To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated
interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid
virologic response rates at least 35% greater than those with placebo.
interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid
virologic response rates at least 35% greater than those with placebo.
Inclusion Criteria:
- Patients chronically infected with hepatitis C virus (HCV) genotype 1 or 4
- HCV RNA viral load of ≥100,000 IU/mL
- No previous exposure to interferon, pegIFNα, or RBV
- Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months
prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1
infection are eligible, but will be capped at 10% of the randomized study population
(biopsy can be from any time period prior to randomization)
- Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12
months prior to randomization that do not demonstrate evidence of hepatocellular
carcinoma
- Body mass index of 18 to 35 kg/m^2
Exclusion Criteria:
- Positive for hepatitis B or HIV-1/HIV-2 antibody at screening
- Evidence of a medical condition associated with chronic liver disease other than HCV
- Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Miami A private research university with more than 15,000 students from around the...
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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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