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NCT01577069 Clinical Trial

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

Chronic Hepatitis C Clinical Trial

— GENUPI  

Official title:
Predictive Factors of the Treatment Failure in HCV Mono-infected Patients Treated With Pegylated-interferon/Ribavirin/Telaprevir.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01577069
Other study ID # UDPS-100211
Secondary ID
Status Completed
Phase N/A
First received April 12, 2012
Last updated June 21, 2016
Start date February 2011
Est. completion date January 2013

Study information
Verified date June 2016
Source Association HGE CHU Bordeaux Sud
Contact n/a
Is FDA regulated No
Health authority France: Committee for the Protection of Personnes
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date January 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- HCV mono-infected subjects

- Age > 18 years

Exclusion Criteria:

- HBV co-infection

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
France Hôpital du haut-Lévêque Pessac

Sponsors (2)
Lead Sponsor Collaborator
Association HGE CHU Bordeaux Sud University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary virological resitance 12 weeks after treatment No
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