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Effects of 48 Weeks Versus 24 Weeks of Therapy With Peg-Intron/Ribavirin in Patients With Chronic Hepatitis C, Genotype 3 (Study P04143)(TERMINATED)

NCT00255034 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2017-04-06

Study results available
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Summary

This is an Australian, open-label, multicenter, randomized, double-blind clinical trial designed to assess the efficacy of combination therapy with pegylated interferon alfa-2b and ribavirin for 48 weeks versus 24 weeks in the treatment of chronic hepatitis C (treatment-naïve genotype 3 subjects with high viral loads who have a METAVIR score of at least F1A2). The primary endpoint will be a sustained virological response defined by undetectable HCV RNA in serum at 24 weeks after completion of therapy.

Conditions

  • Hepatitis C, Chronic

Interventions

BIOLOGICAL

Peginterferon alfa-2b

Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 24 weeks

BIOLOGICAL

Peginterferon alfa-2b

Powder for injection in Redipen (50, 80, 100, 120 and 150 microgram strengths), subcutaneous, dose of 1.5 micrograms/kg, weekly for up to 48 weeks

DRUG

Ribavirin

200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 24 weeks

DRUG

Ribavirin

200 mg capsules, oral, weight-based dose of 800, 1000, or 1200 mg, daily for up to 48 weeks

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-02-28
Primary Completion
2008-06-30
Completion
2008-06-30

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00255034 on ClinicalTrials.gov