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

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ClinicalTrials.gov Identifier: NCT00299936
Recruitment Status : Completed
First Posted : March 7, 2006
Last Update Posted : March 7, 2006
Information provided by:

Study Description
Brief 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

Condition or disease Intervention/treatment Phase
Chronic Hepatitis C Drug: Ribavirin, PEG-Intron Phase 3

Detailed 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


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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00299936

Sponsors and Collaborators
Weill Medical College of Cornell University
Principal Investigator: Ira M Jacobson, MD Weill Medical College of Cornell University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00299936     History of Changes
Other Study ID Numbers: P02314
First Posted: March 7, 2006    Key Record Dates
Last Update Posted: March 7, 2006
Last Verified: March 2006

Keywords provided by Weill Medical College of Cornell University:
hepatitis C
chronic hepatitis C

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Peginterferon alfa-2b
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents