3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals

Terminated

• Conditions: Hepatitis C

• Registration Number: NCT01721265
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

All subjects in this study have previously been in an Idenix HCV study and received study drug for 3 consecutive days. Subjects who had received placebo in a previous Idenix study will not be enrolled in this study.

In this study, researchers will try to find answers to these questions:

* How much (if any) hepatitis C virus is in your blood after stopping your Idenix study drug?

* Is your hepatitis C virus possibly resistant to treatment with the Idenix study drug or similar drugs?

Detailed Description

The data obtained from this study will be used to further understand the long-term efficacy of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to Idenix DAAs.

Study Timeline

• Study Start: 2012-10
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-04
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-15
• Last Update Posted: 2015-04-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 145

Inclusion Criteria

• Read and signed the written informed consent form (ICF) after the nature of the study has been fully explained
• Have participated in an Idenix-sponsored study of an Idenix DAA
• Received at least 3 consecutive days of DAA treatment in an Idenix-sponsored study
• Agreed to comply with the visit schedule and laboratory tests

Exclusion Criteria

• Treatment with placebo only, in an Idenix sponsored study
• Antiviral treatment for HCV after participation in an Idenix sponsored study of an Idenix DAA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Durability of Sustained viral response [SVR]	every 3 months	To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.

Secondary Outcome Measures

Name	Time	Method
Kinetics of resistant variants	every 3 months	To describe the kinetics of resistant variants to Idenix direct acting antivirals (DAAs) by HCV RNA sequencing. The presence of each identified resistant variant in the viral population will be descriptively evaluated until the viral population consists entirely of wild-type virus or over a period of 3 years, whichever comes first.