Study of Patients With Chronic Hepatitis C Infected With HCV LVL G1 and Effect of Peg-Intron Plus Rebetol Treatment (Study P04793)

Completed

• Conditions: Hepatitis C
• Interventions: Drug: PegIntron; Drug: Rebetol

• Registration Number: NCT00709228
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

To determine the relapse rate at 24 weeks follow up in Hepatitis C Virus Genotype 1 Low Viral Load (HCV LVL G1) patients treated for 24 weeks with Peg Intron and Rebetol who are Hepatitis C Virus-Ribonucleic Acid (HCV-RNA) negative at treatment week 4 and week 24. To determine the proportion of patients (%) with sustained virological response at 24 weeks post follow up treatment.

Detailed Description

Approximately 500 patients from about 100 sites to be identified as HCV LVL G1 patients

Study Timeline

• Study Start: 2006-05
• Study First Submitted: 2008-06-23
• Study First Submitted QC: 2008-07-02
• Study First Posted: 2008-07-03
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2009-11-09
• Results First Submitted QC: 2010-01-28
• Results First Posted: 2010-02-22
• Status Verified: 2015-01
• Last Update Submitted: 2015-01-14
• Last Update Posted: 2015-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 496

Inclusion Criteria

• Willingness to participate
• 18 years or older, either gender, any race
• Must have Hepatitic C Virus Low Viral Load [LCV LVL] (positive, but <600,000 IU/mL on the assay used by the individual study site. Only Hepatitis C Virus-Ribonucleic acid/quantitative polymerase chain reaction [HCV-RNA/qPCR] assays with results in IU/ml are acceptable) AND been diagnosed with Genotype 1
• Subject considered suitable for treatment per local label
• Investigator considers suitable and subject consents to be treated

Exclusion Criteria

• Does not show negative polymerase chain reaction [PCR] at week 4
• Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
• Subject does not qualify based on contra-indication, special warning, special population, and/or pregnancy & lactation section of the Summary of Product Characteristics [SmPC]

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PegIntron plus Rebetol	Rebetol	Those with chronic Hepatitis C infected with HCV LVL G1
PegIntron plus Rebetol	PegIntron	Those with chronic Hepatitis C infected with HCV LVL G1

Primary Outcome Measures

Name	Time	Method
Number of HCV LVL G1 Participants Who Relapsed	Week 24 of follow-up	Relapse was defined as undetectable Hepatitis C virus-ribonucleic acid (HCV-RNA) at End of Treatment, but detectable HCV-RNA at Follow-up Week 24.