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

Study Overview
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Brief Summary
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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.

Official Title
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SEASON South East Asian Study Of Novel Genotypes in Hepatitis C Infection: Pegylated-Interferon and Ribavirin Therapy (PEGATRON REDIPEN Combination Therapy (PEG-Intron® REDIPEN Plus REBETOL®)) in Treatment Naive Patients With Genotypes 1, 6, 7, 8, 9: A Comparison of Race and Genotype on Treatment Outcome.

Conditions
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Hepatitis C, Chronic

Intervention / Treatment
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* Biological: peginterferon alfa-2b
* Drug: ribavirin
* Biological: peginterferon alfa-2b
* Drug: ribavirin


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Genotype 1 SEA PEG-IFN/RIB 48 w<br>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 | Biological: peginterferon alfa-2b<br>* 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<br>* Other names: SCH 54031, PegIntron REDIPEN;Drug: ribavirin<br>* 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks<br>* Other names: SCH 18908, REBETOL;|
| Active Comparator: Genotype 1 Caucasian PEG-IFN/RIB 48 w<br>Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy | Biological: peginterferon alfa-2b<br>* 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<br>* Other names: SCH 54031, PegIntron REDIPEN;Drug: ribavirin<br>* 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks<br>* Other names: SCH 18908, REBETOL;|
| Experimental: Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w<br>Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy | Biological: peginterferon alfa-2b<br>* 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<br>* Other names: SCH 54031, PegIntron REDIPEN;Drug: ribavirin<br>* 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 24 weeks<br>* Other names: SCH 18908, REBETOL;|
| Active Comparator: Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w<br>Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy | Biological: peginterferon alfa-2b<br>* 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<br>* Other names: SCH 54031, PegIntron REDIPEN;Drug: ribavirin<br>* 200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg daily for up to 48 weeks<br>* Other names: SCH 18908, REBETOL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Who Achieved a Sustained Virologic Response (SVR) | SVR is defined as negative hepatitis C virus ribonucleic acid (HCV RNA) in serum at 24 weeks after therapy completion. The study was terminated early due to slow enrollment. The primary outcome measure could not be assessed. | 24 weeks after completion of either up to 24 or 48 weeks of therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic hepatitis C, pegylated interferon alfa-2b, ribavirin, Asia