NCT01721265

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?

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 5, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

2.4 years

First QC Date

October 31, 2012

Last Update Submit

April 15, 2015

Conditions

Hepatitis C

Keywords

HCVHepatitis CIDX184IDX719

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Kinetics of resistant variants

    every 3 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The population will include subjects who participated in studies of Idenix anti-HCV DAAs.

You may qualify if:

  • 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

You may not qualify if:

  • Treatment with placebo only, in an Idenix sponsored study
  • Antiviral treatment for HCV after participation in an Idenix sponsored study of an Idenix DAA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human plasma

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2012

First Posted

November 5, 2012

Study Start

October 1, 2012

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

April 16, 2015

Record last verified: 2015-04