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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 is currently recruiting participants.
Verified November 2012 by Idenix Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Idenix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01721265
First received: October 31, 2012
Last updated: November 1, 2012
Last verified: November 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Idenix Pharmaceuticals:

Primary Outcome Measures:
  • Durability of Sustained viral response [SVR] [ Time Frame: every 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 183
Study Start Date: October 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: August 2016 (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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721265

Contacts
Contact: John Z Sullivan-Bolyai, MD, MPH 1877-433-6491 Sullivan-Bolyai.John@idenix.com

Locations
United States, Kansas
Recruiting
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Idenix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Idenix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01721265     History of Changes
Other Study ID Numbers: IDX-03YF
Study First Received: October 31, 2012
Last Updated: November 1, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Idenix Pharmaceuticals:
HCV
Hepatitis C
IDX184
IDX719

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
 Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013