3-Year Observational Virology Follow-up Study in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
| Status: | Recruiting |
|---|---|
| Conditions: | Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 2/8/2015 |
| Start Date: | October 2012 |
| End Date: | December 2016 |
| Contact: | John Z Sullivan-Bolyai, MD, MPH |
| Email: | Sullivan-Bolyai.John@idenix.com |
| Phone: | 1877-433-6491 |
3-Year, Observational Study to Evaluate the Durability of Sustained Viral Response and the Kinetics of Antiviral-Resistant HCV in Subjects Who Participated in Studies of Idenix Anti-HCV, Direct Acting Antivirals
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?
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?
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.
of Idenix DAAs used to treat HCV infection and to further understand HCV resistance to
Idenix DAAs.
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
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