Clinical trial NCT00255008: Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)
Official title: 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.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatitis C, Chronic
Keywords: chronic hepatitis C
pegylated interferon alfa-2b
ribavirin
Asia
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2005-11-17
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Subjects Who Achieved a Sustained Virologic Response (SVR)
timeFrame: 24 weeks after completion of either up to 24 or 48 weeks of therapy
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: