Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)

• Status: Terminated
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Merck Sharp & Dohme Corp.
• Treatments: Interferon-alpha; Interferons; Peginterferon alfa-2b; Ribavirin

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.