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

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ClinicalTrials.gov Identifier: NCT01721265
Recruitment Status : Terminated
First Posted : November 5, 2012
Last Update Posted : April 16, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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?

Condition or disease
Hepatitis C

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 Type : Observational
Actual Enrollment : 145 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : October 2012
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Durability of Sustained viral response [SVR] [ Time Frame: every 3 months ]
    To evaluate the durability of sustained virological response (SVR). Plasma HCV RNA levels will be monitored over time.


Secondary Outcome Measures :
  1. Kinetics of resistant variants [ Time Frame: 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.


Biospecimen Retention:   Samples Without DNA
Human plasma


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population will include subjects who participated in studies of Idenix anti-HCV DAAs.
Criteria

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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01721265     History of Changes
Other Study ID Numbers: 1894-009
IDX-03YF
First Posted: November 5, 2012    Key Record Dates
Last Update Posted: April 16, 2015
Last Verified: April 2015

Keywords provided by Merck Sharp & Dohme Corp.:
HCV
Hepatitis C
IDX184
IDX719

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Antiviral Agents
Anti-Infective Agents