Use of Direct-acting Antiviral to Treat HCV Recurrence After Liver Transplantation (ANRSCO23CUPILT) Infection

Liver Transplantation Clinical Trial

— ANRSCO23CUPILT  

Official title:

Cohort of Liver Transplanted Patients With Hepatitis C Virus Recurrence and Treated With Direct-acting Antiviral Agents

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01944527
• Other study ID #: 2013-A00941-44
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2013
• Last updated: February 1, 2016
• Start date: October 2013
• Est. completion date: June 2017

Study information

• Verified date: February 2016
• Source: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 699
• Est. completion date: June 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort

Related Conditions & MeSH terms

• Direct-acting Antiviral Agents
• HCV Recurrence
• Liver Transplantation
• Recurrence

Locations

Country	Name	City	State
France	Claire Fougerou	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of sustained virological response 12 weeks after discontinuation of direct-acting anti-HCV therapy in liver transplanted patients with HCV recurrence	Sustained virological response (SVR) at 12 weeks after the end of the treatment (SVR defined as undetectable HCV RNA measured by PCR en real time at 12 weeks after antiviral therapy discontinuation)	12 weeks after discontinuation of therapy	No
Secondary	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	Detectability of HCV RNA according to real time PCR	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	No
Secondary	Tolerability of direct acting antiviral HCV agents	Clinical and laboratory parameters (hepatic, renal, hematological in particular) to assess safety and recording of adverse events	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	No
Secondary	Drug-drug interactions	Trough blood concentration of immunosuppressive drugs	Baseline, 1,2,4,12,16, 24, 48 weeks during treatement and 4weeks after treatment discontinuation	No
Secondary	To evaluate emergence of viral resistance to direct-acting antivirals agents		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	No
Secondary	To establish predictive factors of treatment failure and of emergence of viral resistance	The rate of anticipated antiviral treatment discontinuation because of intolerability or of severe adverse events	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	No
Secondary	Evaluate the incidence of graft loss and acute rejection	The rate of graft loss	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	No
Secondary	Impact on concomitant therapy on virological responses and safety		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	No