Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection

• Status: Completed
• Trial end date: 2012-09-01
• Target enrollment: 0
• Participant gender: All

Summary

To identify a shorter duration of antiviral therapy (12 or 16 weeks) for the combination of daclatasvir with pegylated interferon alfa-2a and ribavirin.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a; Ribavirin

Criteria

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