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)

Merck Sharp & Dohme (MSD)

Status: Completed

Conditions: Hepatitis C

Treatments: Drug: Standard of Care Ribavirin; Drug: Standard of Care PegIntron

Study type: Observational

Funder types: Industry

Identifiers

NCT01054742

P04793 Part 2

Details and patient eligibility

About

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.

Full description

All study activities were consistent with the EU Directive 2001/20/EC section for non-interventional studies (i.e. observational studies). Medicinal products are prescribed in the usual manner in accordance with the terms of the marketing authorization. The assignment of the participant to a particular therapeutic strategy is not decided in advance by the trial protocol but falls within current practice and the prescription of the medicine is clearly separated from the decision to include the patient in the study.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Willingness to participate
• 18 years or older, either gender, any race
• Participant has relapsed at the end of the Part 1 follow-up phase (defined as having a positive virology result at 24 weeks of follow-up post treatment after a negative result at the Week 24 end-of-treatment time point)
• Participant considered suitable for treatment per local label
• Investigator considers suitable and participant consents to be treated

Exclusion criteria

• Pregnant women or those who plan to become pregnant or sexual partners of women who plan to become pregnant
• Participant does not qualify based on contra-indication, special warning, special population, and/or pregnancy & lactation section of the SmPC

Trial design

2 participants in 1 patient group

Standard of Care PegIntron Plus Ribavirin [Part 2]

Description:

Participants who had relapsed during Part 1 of the study, had detectable HCV-RNA on Day 1 of Part 2 of the study, and who were re-treated during Part 2 of the study with standard of care PegIntron plus ribavirin for 48 weeks.

Treatment:

Drug: Standard of Care PegIntron

Drug: Standard of Care Ribavirin