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NCT00299936 Clinical Trial

Comparison of PEG-Intron and Two Different Doses of Ribavirin for the Treatment of Chronic Hepatitis C In Treatment Naïve Subjects

Chronic Hepatitis C Clinical Trial

Official title:
Comparison of PEG Interferon Alfa-2b Plus Ribavirin Given as a Fixed Dose or on a Weight Optimized Basis for Treatment of Chronic Hepatitis C in Previously Untreated Adult Subjects

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00299936
Other study ID # P02314
Secondary ID WIN-R
Status Completed
Phase Phase 3
First received March 3, 2006
Last updated March 3, 2006

Study information
Verified date March 2006
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 5000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Ribavirin, PEG-Intron

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Weill Medical College of Cornell University Schering-Plough
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