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

This study has been terminated.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01721265
First Posted: November 5, 2012
Last Update Posted: April 16, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
  Purpose

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
Hepatitis C

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 145
Study Start Date: October 2012
Study Completion Date: March 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01721265     History of Changes
Other Study ID Numbers: 1894-009
IDX-03YF
First Submitted: October 31, 2012
First Posted: November 5, 2012
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