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

This study has been completed.
Information provided by (Responsible Party):
Association HGE CHU Bordeaux Sud Identifier:
First received: April 12, 2012
Last updated: July 29, 2015
Last verified: July 2015

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.

Chronic Hepatitis C

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictive Factors of the Treatment Failure in HCV Mono-infected Patients Treated With Pegylated-interferon/Ribavirin/Telaprevir.

Resource links provided by NLM:

Further study details as provided by Association HGE CHU Bordeaux Sud:

Primary Outcome Measures:
  • virological resitance [ Time Frame: 12 weeks after treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 73
Study Start Date: February 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • HBV co-infection
  Contacts and Locations
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Please refer to this study by its identifier: NCT01577069

Hôpital du haut-Lévêque
Pessac, France, 33604
Sponsors and Collaborators
Association HGE CHU Bordeaux Sud
Principal Investigator: Victor de lédinghen, MD, PhD University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: Association HGE CHU Bordeaux Sud Identifier: NCT01577069     History of Changes
Other Study ID Numbers: UDPS-100211
Study First Received: April 12, 2012
Last Updated: July 29, 2015
Health Authority: France: Committee for the Protection of Personnes

Keywords provided by Association HGE CHU Bordeaux Sud:
Hepatitis C
Direct Antiviral agent (DAA)
Ultra-deep pyrosequencing
Single polynucleotide polymorphisms
Treatment-resistant mutants
Hepatitis C Virus Protease Inhibitor

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Hepatitis, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases processed this record on November 30, 2015