Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 4/21/2016 |
Start Date: | December 2010 |
End Date: | September 2012 |
A Phase 2B Pilot Study of Short-Term Treatment of BMS-790052 in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 2 or 3 Infection
To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of
daclatasvir with pegylated interferon alfa-2a and ribavirin.
daclatasvir with pegylated interferon alfa-2a and ribavirin.
Key Inclusion Criteria:
- Participants chronically infected with hepatitis C virus (HCV) genotype 2 or 3
- No previous exposure to an interferon formulation (ie, interferon alfa, pegylated
interferon alfa-2a ) or ribavirin
- Body mass index (BMI) of 18 to 35 kg/m^2, inclusive. BMI=weight (kg)/height (m)^2
- Males and females, 18 - 70 years of age
Key Exclusion Criteria:
- Liver transplant recipients
- Documented or suspected hepatocellular carcinoma
- Evidence of decompensated cirrhosis
- History of chronic hepatitis B virus (HBV). Patients with resolved HBV infection may
participate
- Current or known history of cancer
- Any gastrointestinal disease or surgical procedure that may impact the absorption of
study drug
- Inability to tolerate oral medication
- Poor venous access
- Severe psychiatric disease
- History of chronic pulmonary disease
- History of cardiomyopathy, coronary artery disease (including angina), interventive
procedure for coronary artery disease (including angioplasty, stent procedure, or
cardiac bypass surgery), ventricular arrhythmia,, or other clinically significant
cardiac disease
- History of or current electrocardiogram findings indicative of cardiovascular
instability
- Preexisting ophthalmologic disorders considered clinically significant on eye
- History of uncontrolled diabetes mellitus
- Any known contraindication to pegylated interferon alfa-2a or ribavirin not otherwise
specified.
- Positive hepatitis B virus surface antigen, HIV-1 or HIV-2 Ab
- Prior exposure to any HCV direct antiviral agent (eg, HCV protease, polymerase,
previous nonstructural protein 5A inhibitors)
- Exposure to any investigational drug or placebo
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