Status:
TERMINATED
Peg-Intron and Rebetol Therapy in Treatment of Naive Hepatitis C Patients: A Comparison of Race and Genotype on Treatment Outcome (Study P04212)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00255008
Start Date
March 1 2005
End Date
December 1 2007
Last Update
April 6 2017
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