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Observational Study of Patients With Chronic Hepatitis C Virus (HCV) Infected With HCV Genotype 1 Low Virus Load (LVL 1) and Effect of PegIntron Plus Rebetol Treatment (Study P04793 Part 2)

NCT01054742 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2

Last updated 2015-01-16

Study results available
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Summary

The purpose of this observational study was to provide summary data from participants who relapsed at the end of the follow-up phase after 24 weeks of treatment with standard care PegIntron plus ribavirin in Part 1 of the study (NCT00709228) and who then received retreatment during Part 2 of the study. Relapse was defined as having a positive virology result at the Week 24 post-treatment follow-up, after a negative result at the Week 24 end-of-treatment time point. Hepatitis C Virus Ribonucleic Acid (HCV-RNA) levels were measured at Day 1 and Weeks 12, 24, and 48 of the extension, and at Follow-up Week 24.

Conditions

  • Hepatitis C

Interventions

DRUG

Standard of Care PegIntron

Commercially available PegIntron administered subcutaneously (SC) at 1.5 μg/kg weekly in accordance with the PegIntron Summary of Product Characteristics (SmPC).

DRUG

Standard of Care Ribavirin

Commercially available ribavirin administered orally at 800-1200 mg/day based on body weight in accordance with the ribavirin SmPC.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-06-30
Completion
2011-06-30

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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 NCT01054742 on ClinicalTrials.gov