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

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01721265
• Other study ID #: 1894-009
• Secondary ID: IDX-03YF
• Status: Terminated
• Phase: N/A
• First received: October 31, 2012
• Last updated: April 15, 2015
• Start date: October 2012
• Est. completion date: March 2015

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 145
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis C

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Durability of Sustained viral response [SVR]	To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.	every 3 months	No
Secondary	Kinetics of resistant variants	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.	every 3 months	No