Clinical Trials Logo
  1. Home
  2. Chronic Hepatitis C
  3. NCT01577069
  4. Details
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
See also
  Status Clinical Trial Phase
Completed NCT01937975 - The Pharmacokinetics of Grazoprevir (MK-5172) and Elbasvir (MK-8742) in Participants With Renal Insufficiency (MK-5172-050) Phase 1
Completed NCT03673696 - The Tolerability and Pharmacokinetics Study of HEC74647PA Capsule in Healthy Adult Subjects Phase 1
Completed NCT02250001 - Asunaprevir/Daclatasvir Safety Surveillance in Japanese Patients With Chronic Hepatitis C N/A
Completed NCT03088917 - 'Fibrosis in the Lost Hepatitis C Population - Track, Trace and Treat'
Completed NCT02207088 - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease Phase 3
Not yet recruiting NCT02865369 - Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment N/A
Recruiting NCT02638233 - Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy Phase 4
Not yet recruiting NCT02511496 - Status of Chronic Liver Disease in Hepatitis C Virus (HCV) Patients Coinfected With Human Immunodeficiency Virus (HIV) in Andalusia N/A
Completed NCT02788682 - Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy N/A
Not yet recruiting NCT01949168 - A Pilot Study of Boceprevir for the Treatment of Genotype 6 HCV Phase 2
Completed NCT01439776 - Add Vitamin D With Standard of Care for Chronic Hepatitis C Patients Phase 4
Recruiting NCT01360879 - Assessment of Liver FIBROsis by Real-time Tissue ELASTography in Chronic Liver Disease N/A
Recruiting NCT01360892 - Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography N/A
Completed NCT00968357 - Proof-of-concept Study to Evaluate the Safety and Immunomodulatory Effects of SCV 07 as Monotherapy or in Combination With Ribavirin in Noncirrhotic Subjects With Chronic Hepatitis C Who Have Relapsed Phase 2
Terminated NCT00962936 - Safety and Tolerability Study of the Monoclonal Antibody CT-011 in Patients With Chronic Hepatitis C Genotype I Infection Phase 1/Phase 2
Recruiting NCT01178749 - Exploration of Chronic Hepatitis C Infection Receiving 24-week Interferon-α With Ribavirin Treatments N/A
Recruiting NCT00575627 - Pegylated-Interferon and Ribavirin in Hepatitis C Patients With Persistently Normal Alanine Aminotransferase Levels Phase 4
Completed NCT00537407 - A Study of Debio 025 in Combination With PegIFN Alpha-2a and Ribavirin in Chronic HCV Patients Non-responders to Standard Treatment Phase 2
Recruiting NCT00370617 - Pegylated-Interferon and Ribavirin Plus Metformin in the Treatment of Chronic HCV Infection and Insulin Resistance Phase 4
Completed NCT01684787 - Study to Evaluate the Treatment for Chronic Hepatitis C With Normal Transaminases in HIV Positive Patients Phase 4