Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Intervention: peginterferon alfa-2b; ribavirin; peginterferon alfa-2b; 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 48 weeks; 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 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 24 weeks; 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 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: 121.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: chronic hepatitis C; pegylated interferon alfa-2b; ribavirin; Asia

Summary:

      This is a multicenter clinical trial designed to compare the efficacy of 48 weeks of therapy
      with pegylated (PEG)-Interferon/ribavirin in Southeastern Asian patients with genotype 1
      chronic hepatitis C with 48 weeks of therapy with PEG-Interferon/ribavirin in Caucasian
      patients with genotype 1 chronic hepatitis C. This study is also designed to provide a
      randomized comparison of 24 weeks versus 48 weeks of therapy with PEG-Interferon/ribavirin in
      Southeastern Asian patients with genotypes 6-9. The primary endpoint is sustained virologic
      response, as defined by negative hepatitis C virus (HCV) ribonucleic acid (RNA) in serum at
      24 weeks after therapy completion.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Comply with all current Australian Schedule of Pharmaceutical Benefits S100
             eligibility criteria.

          -  Able to give written informed consent and adhere to study visit schedule.

          -  South East Asian ethnicity (except for Caucasian Gt1/1b in comparator arm) i.e. born
             in Vietnam, Cambodia, Laos, Thailand, Hong Kong, and China or have both parents born
             in these countries.

          -  Genotype 1, 1a, 1b, 6, 6a, 6b, 7, 8, or 9, as classified by INNO-LiPA assay.

          -  Hemoglobin >=120 g/L (females), >=130 g/L (males).

          -  Platelet count >=100 x 10^9/L.

          -  Neutrophil count >=1.5 x 10^9/L.

          -  Negative pregnancy test for females.

          -  Thyroid stimulating hormone (TSH) within normal limits.

        Exclusion Criteria:

          -  Participation in any other investigational drug program within 30 days of the
             Screening Visit.

          -  Human immunodeficiency virus (HIV) antibody positive or hepatitis B surface antigen
             (HBsAg) positive.

          -  Genotype 2, 3, 4, or 5, as classified by INNO-LiPA assay.

          -  Non South East Asian ethnicity (unless recruited to Caucasian GT1 comparator arm).

          -  Evidence of liver disease due to other disorders (e.g., hemachromatosis, Wilson's
             disease).

          -  Ongoing drug or alcohol abuse which in the opinion of the investigator would
             jeopardize the patient's ability to comply with study requirements.

          -  Inability to comply with study requirements for other reasons.

          -  Decompensated cirrhosis (Ascites, history of encephalopathy or bleeding varices, serum
             albumin <35 g/L, prothrombin time (PT) prolonged by greater than 3 sec).

          -  Present or prior history of severe psychiatric disease requiring hospitalization or
             medication.

          -  History of severe seizure disorder.

          -  History of autoimmune disorders (e.g., rheumatoid arthritis, inflammatory bowel
             disease, immune thrombocytopenic purpura, systemic lupus erythematosus, or other mixed
             connective tissue disease, psoriasis, optic neuritis).

          -  Poorly controlled thyroid disease.

          -  Creatinine clearance <50 mL/min.

          -  Severe cardiovascular disease.

          -  Hepatocellular cancer.

          -  Clinically significant ophthalmologic disorders.

          -  Hemoglobinopathies (e.g., thalassemia, sickle-cell anemia).

          -  Treatment or recent treatment with immunosuppressive agents (excluding short-term
             corticosteroid withdrawal), and immunosuppressed transplant recipients scheme.