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Efficacy of PegIntron and Rebetol in Previously Untreated Patients With Chronic Hepatitis C Infected With HCV Genotype 1/4/5/6 (Study P04243)

NCT00709059 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 538

Last updated 2015-11-04

Study results available
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Summary

The objective of the study is to evaluate the effectiveness of PegIntron plus Rebetol combination in treating patients with chronic hepatitis C in a primary care setting. Patients received no antiviral therapy prior to the current study. Only patients infected with Hepatitis C Virus (HCV) genotype 1, 4, 5, or 6 will be enrolled in the study. The study will also explore the influence of liver fibrosis stage on the chances of achieving a sustained virologic response.

Conditions

  • Hepatitis C, Chronic

Interventions

BIOLOGICAL

PegIntron (peginterferon alfa-2b; SCH 54031)

PegIntron 1.5 ug/kg body weight per week subcutaneously for 48 weeks

DRUG

Rebetol (ribavirin; SCH 18908)

Rebetol administered based on body weight 800-1200 mg/day (\<65 kg: 800 mg; 65 - 85 kg: 1000 mg; \>85 kg: 1200 mg) orally for 48 weeks

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-12-31
Primary Completion
2009-12-31
Completion
2009-12-31

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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 NCT00709059 on ClinicalTrials.gov