Study in Genotype 2 or 3 Patients With Chronic Hepatitis Virus Infection
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Intervention: Placebo; Daclatasvir; Pegylated interferon alfa-2a; Ribavirin
Intervention description: Tablets, oral, 0 mg, once daily, for 24 weeks; Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks; Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks; Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
Intervention MeSH terms: Interferons; Ribavirin; Interferon-alpha; Interferon alpha-2; Peginterferon alfa-2a
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 196.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No

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.
    

Eligibility 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