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

Merck Sharp & Dohme (MSD)

Status: Terminated

Conditions: Hepatitis C

Study type: Observational

Funder types: Industry

Identifiers

NCT01721265

IDX-03YF

1894-009

Details and patient eligibility

About

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?

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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