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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Association HGE CHU Bordeaux Sud.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Association HGE CHU Bordeaux Sud
ClinicalTrials.gov Identifier:
NCT01577069
First received: April 12, 2012
Last updated: NA
Last verified: March 2012
History: No changes posted
  Purpose

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
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
Estimated Study Completion Date: December 2013
  Eligibility

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)

Criteria

Inclusion Criteria:

  • HCV mono-infected subjects
  • Age > 18 years

Exclusion Criteria:

  • HBV co-infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577069

Locations
France
Hôpital du haut-Lévêque Recruiting
Pessac, France, 33604
Contact: Wassil Merrouche    00 33 5 57 65 63 11    wassil.merrouche@chu-bordeaux.fr   
Sub-Investigator: Pascale Trimoulet         
Sponsors and Collaborators
Association HGE CHU Bordeaux Sud
Investigators
Principal Investigator: Victor de lédinghen, MD, PhD University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: Association HGE CHU Bordeaux Sud
ClinicalTrials.gov Identifier: NCT01577069     History of Changes
Other Study ID Numbers: UDPS-100211
Study First Received: April 12, 2012
Last Updated: April 12, 2012
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
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on August 28, 2014