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

This study has been completed.
University Hospital, Bordeaux
Information provided by (Responsible Party):
Association HGE CHU Bordeaux Sud Identifier:
First received: April 12, 2012
Last updated: June 21, 2016
Last verified: June 2016

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 ]

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   (Adult, Senior)
Sexes Eligible for Study:   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:

  • HBV co-infection
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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
University Hospital, Bordeaux
Principal Investigator: Victor de lédinghen, MD, PhD University Hospital, Bordeaux
  More Information

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: June 21, 2016

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, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections processed this record on April 27, 2017