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CompletedNCT01577069GENUPIUpdated Jun 22, 2016

Predictive Factors of the Treatment Failure in Hepatitis C Virus (HCV) Infected Patients Treated With Telaprevir

An observational study in Chronic Hepatitis C, sponsored by Association HGE CHU Bordeaux Sud. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-06-22.

Sponsored by Association HGE CHU Bordeaux Sud · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
73
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of the study is to

1- detect and quantify HCV-PI resistant mutants with ultra-deep pyrosequencing (UDPS) technology, 2 - detect SNPs in P-glyocoprotein and CYP3A genes, in HCV mono-infected patients under/after Telaprevir treatment.

02

Conditions studied

  • Chronic Hepatitis C

Keywords

  • Hepatitis C
  • Direct Antiviral agent (DAA)
  • Ultra-deep pyrosequencing
  • Single polynucleotide polymorphisms
  • Treatment-resistant mutants
  • Hepatitis C Virus Protease Inhibitor
03

In context

Hepatitis A

2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.

This study's planned enrollment of 73 is below the median of 250 across 687 observational studies indexed under Hepatitis A.

Browse Hepatitis A studies →

Lead sponsor

Association HGE CHU Bordeaux Sud is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

HCV mono-infected patients treated in the Hepatology Unit of Pr Victor de Lédinghen (Hôpital du Haut-Lévêque, Pessac)

Inclusion criteria

  • HCV mono-infected subjects
  • Age > 18 years

Exclusion criteria

Exclusion Criteria:

  • HBV co-infection
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
73 participants (estimated)
06

What researchers measure

Primary outcomes

  1. virological resitance

    Time frame: 12 weeks after treatment

07

Study locations

1 site
  • Hôpital du haut-Lévêque
    Pessac, 33604, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 22, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01577069
Lead sponsor
Association HGE CHU Bordeaux Sud
Collaborators
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Apr 13, 2012
Start date
Feb 2011
Primary completion
Jan 2013
Completion
Jan 2013
Last update
Jun 22, 2016

Study contacts

Victor de lédinghen, MD, PhD
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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