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

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C

Treatments: Drug: Rebetol; Drug: PegIntron

Study type: Observational

Funder types: Industry

Identifiers

NCT00709228

P04793

Details and patient eligibility

About

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.

Full description

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

Enrollment: 496 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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]

Trial design

496 participants in 1 patient group

PegIntron plus Rebetol

Description:

Those with chronic Hepatitis C infected with HCV LVL G1

Treatment:

Drug: PegIntron

Drug: Rebetol