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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01577069
Recruitment Status : Completed
First Posted : April 13, 2012
Last Update Posted : June 22, 2016
University Hospital, Bordeaux
Information provided by (Responsible Party):
Association HGE CHU Bordeaux Sud

Brief 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.

Condition or disease
Chronic Hepatitis C

Study Type : Observational
Estimated Enrollment : 73 participants
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.
Study Start Date : February 2011
Actual Primary Completion Date : January 2013
Actual Study Completion Date : January 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. virological resitance [ Time Frame: 12 weeks after treatment ]

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Association HGE CHU Bordeaux Sud Identifier: NCT01577069     History of Changes
Other Study ID Numbers: UDPS-100211
First Posted: April 13, 2012    Key Record Dates
Last Update Posted: June 22, 2016
Last Verified: June 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