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3-Year Observational Virology...

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

Last Updated: 2015-04-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

145 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-03-31

Brief Summary

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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?

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Detailed Description

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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.

Conditions

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Hepatitis C

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers