Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects
Status and phase
Conditions
Treatments
Details and patient eligibility
About
The purpose of this study is to compare PEG-interferon alfa-2b and two different doses of rivavirin for the treatment of chronic hepatitis C in previously untreated adult subjects
Full description
Primary Objective:
This study will evaluate the safety and efficacy of two different PEG-interferon and Ribavirin regimens in patients who have not previously been treated for Hepatitis C. Patients have an equal chance to assignment to one of two treatment arms:
Treatment Arm A:
PEG-interferon 1.5 mcg/kg2 QW + Ribavirin 800 mg/day
OR
Treatment Arm B:
PEG-interferon 1.5mcg/kg2 QW + Ribavirin 800 to 1400 mg/day
Arm A & Arm B: Duration of treatment will be 48 weeks for genotype 1 patients and 24 or 48 weeks for genotype 2 or 3 patients.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Adult naive subjects with a diagnosis of compensated chronic hepatitis C (HCV RNA+) who have not previously been treated with interferon, PEG-interferon, ribavirin, or combination interferon + ribavirin are being selected for the study.
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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