Overview

This trial is active, not recruiting.

Conditions hcv recurrence, liver transplantation, direct-acting antiviral agents
Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Start date October 2013
End date December 2015
Trial size 699 participants
Trial identifier NCT01944527, 2013-A00941-44

Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of direct-acting antivirals therapy in liver transplanted patients who experienced HCV recurrence.

This cohort is multicentric with constitution of biobank (plasma, serum) and the prospective collect of biological and clinical data's in the liver transplanted patients with recurrent HCV infection and treated with direct-acting anti-HCV agents.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort

Primary Outcomes

Measure
The rate of sustained virological response 12 weeks after discontinuation of direct-acting anti-HCV therapy in liver transplanted patients with HCV recurrence
time frame: 12 weeks after discontinuation of therapy

Secondary Outcomes

Measure
Virological responses at 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation
time frame: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
Tolerability of direct acting antiviral HCV agents
time frame: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation
Drug-drug interactions
time frame: Baseline, 1,2,4,12,16, 24, 48 weeks during treatement and 4weeks after treatment discontinuation
To evaluate emergence of viral resistance to direct-acting antivirals agents
time frame: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
To establish predictive factors of treatment failure and of emergence of viral resistance
time frame: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
Evaluate the incidence of graft loss and acute rejection
time frame: Day 0, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatement and 4,12,24,48 weeks after treatment discontinuation
Impact on concomitant therapy on virological responses and safety
time frame: Baseline, 1,2,3,4,6,8,12,16, 20, 24, 36, 48 weeks during treatment and 4,12,24,48 weeks after treatment discontinuation

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age > 18 years-old - Liver transplanted patient - Hepatitis C virus infection before transplantation - HCV recurrence with a detectable HCV RNA before enrollment in cohort - Use of at least one direct-acting antiviral agents with or without association with peginterferon and with or without association with ribavirin - Treated by direct-acting antiviral agents or has been yet completed the treatment but still on follow up - Affiliated to Health Insurance - Written Signed consent form Exclusion Criteria: - Pregnant or breast-feeding female

Additional Information

Official title Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents
Principal investigator Georges Philippe Pageaux, Professsor
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).