Recruitment targets were unachievable in the currently available population.

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.

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.

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf

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