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

NCT ID: NCT00255008

Last Updated: 2017-04-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 121 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-03-31
• Study Completion Date: 2007-12-31

Brief 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.

Conditions

Hepatitis C, Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Genotype 1 SEA PEG-IFN/RIB 48 w

Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PEG-Intron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy

Group Type: ACTIVE_COMPARATOR

peginterferon alfa-2b

Intervention Type: BIOLOGICAL

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

ribavirin

Intervention Type: DRUG

200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks

Genotype 1 Caucasian PEG-IFN/RIB 48 w

Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy

Group Type: ACTIVE_COMPARATOR

peginterferon alfa-2b

Intervention Type: BIOLOGICAL

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

ribavirin

Intervention Type: DRUG

200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks

Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w

Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy

Group Type: EXPERIMENTAL

peginterferon alfa-2b

Intervention Type: BIOLOGICAL

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

ribavirin

Intervention Type: DRUG

200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 weeks

Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w

Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy

Group Type: ACTIVE_COMPARATOR

peginterferon alfa-2b

Intervention Type: BIOLOGICAL

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

ribavirin

Intervention Type: DRUG

200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks

Interventions

peginterferon alfa-2b

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

Intervention Type: BIOLOGICAL

ribavirin

200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks

Intervention Type: DRUG

peginterferon alfa-2b

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

Intervention Type: BIOLOGICAL

ribavirin

200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 weeks

Intervention Type: DRUG

Other Intervention Names

SCH 54031, PegIntron REDIPEN; SCH 18908, REBETOL; SCH 54031, PegIntron REDIPEN; SCH 18908, REBETOL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

P04212

Identifier Type: -

Identifier Source: org_study_id