Effects of 48 Weeks Versus 24 Weeks of Therapy With Peg-Intron/Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (Study P04143)(TERMINATED)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: Peginterferon alfa-2b; Peginterferon alfa-2b; Ribavirin; Ribavirin
Intervention description: Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks; Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks; 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 weeks; 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon-alpha
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 146.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic hepatitis C; pegylated interferon alfa-2b; ribavirin; Australia

Summary:

      This is an Australian, open-label, multicenter, randomized, double-blind clinical trial
      designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and
      ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C
      (treatment-naïve genotype 3 subjects with high viral loads who have a METAVIR score of at
      least F1A2). The primary endpoint will be a sustained virological response defined by
      undetectable HCV RNA in serum at 24 weeks after completion of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Comply with all current Australian Schedule of Pharmaceutical Benefits S100
             eligibility criteria.

          -  Chronic hepatitis C genotype 3 infection with a viral load of at least 2 million
             copies per mL.

          -  Able to give written informed consent.

          -  Understand and be able to adhere to the dosing and visit schedules.

          -  Compensated liver disease with the following minimum hematologic and biochemical
             criteria:

               -  Hemoglobin ≥120 g/L (females), ≥130 g/L (males)

               -  Platelets ≥100 x 10^9/L

               -  Neutrophil count ≥1.5 x 10^9/L

               -  Creatinine clearance >50 mL/minute

               -  Thyroid stimulating hormone (TSH) within normal limits

          -  Serum hepatitis B surface antigen (HBsAg) and human immunodeficiency virus (HIV)
             negative.

          -  Negative pregnancy test.

        Exclusion Criteria:

          -  Suspected hypersensitivity to interferon, pegylated interferon alfa-2b, or ribavirin.

          -  Participation in any other investigational drug program within 30 days of the
             screening visit for this protocol.

          -  Any cause of liver disease based on patient history and biopsy other than chronic
             hepatitis C, including but not limited to: hemochromatosis, alpha-1 antitrypsin
             deficiency, Wilson's disease, autoimmune hepatitis, alcoholic liver disease,
             drug-related liver disease.

          -  Hepatocellular carcinoma.

          -  Decompensated cirrhosis (ascites, history of encephalopathy or bleeding varices, serum
             albumin <35 g/L, prothrombin time (PT) prolonged by greater than 3 sec).

          -  Significant cardiovascular dysfunction within the past 6 months (e.g., angina,
             congestive heart failure, myocardial infarction, severe hypertension, or significant
             arrhythmia) or participants with an ECG showing clinically significant abnormalities.

          -  Immunologically-mediated disease, (e.g. inflammatory bowel disease), idiopathic
             thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia,
             scleroderma, severe psoriasis).

          -  Hemophilia or any hemoglobinopathy, including but not limited to thalassemia major.

          -  Severe psychiatric condition, including major depression, a history of major
             psychoses, current suicidal ideation, and/or suicidal attempts.

          -  Ongoing substance abuse, e.g. alcohol, I.V. drugs or inhalants that in the opinion of
             the investigator would jeopardize the patient's ability to comply with study
             requirements.

          -  Clinically significant ophthalmological disorders.

          -  Treatment or recent treatment with immunosuppressive agents (excluding short-term
             corticosteroid withdrawal) and immunosuppressed transplant recipients.

          -  Poorly controlled thyroid disease.

          -  Any other condition that in the opinion of the investigator would make the patient
             unsuitable for enrolment, or could interfere with the patient participating in and
             completing the clinical trial program.