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

NCT ID: NCT01944527

Last Updated: 2016-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

699 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2017-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

HCV Recurrence Liver Transplantation Direct-acting Antiviral Agents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Georges Philippe Pageaux, Professsor

Role: PRINCIPAL_INVESTIGATOR

HOSPITAL SAINT ELOI

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Claire Fougerou

Rennes, , France

Site Status

Countries

Review the countries where the study has at least one active or historical site.

France

References

Explore related publications, articles, or registry entries linked to this study.

Barrail-Tran A, Goldwirt L, Gele T, Laforest C, Lavenu A, Danjou H, Radenne S, Leroy V, Houssel-Debry P, Duvoux C, Kamar N, De Ledinghen V, Canva V, Conti F, Durand F, D'Alteroche L, Botta-Fridlund D, Moreno C, Cagnot C, Samuel D, Fougerou-Leurent C, Pageaux GP, Duclos-Vallee JC, Taburet AM, Coilly A. Comparison of the effect of direct-acting antiviral with and without ribavirin on cyclosporine and tacrolimus clearance values: results from the ANRS CO23 CUPILT cohort. Eur J Clin Pharmacol. 2019 Nov;75(11):1555-1563. doi: 10.1007/s00228-019-02725-x. Epub 2019 Aug 5.

Reference Type DERIVED
PMID: 31384986 (View on PubMed)

Antonini TM, Coilly A, Rossignol E, Fougerou-Leurent C, Dumortier J, Leroy V, Veislinger A, Radenne S, Botta-Fridlund D, Durand F, Houssel-Debry P, Kamar N, Canva V, Perre P, De Ledinghen V, Rohel A, Diallo A, Taburet AM, Samuel D, Pageaux GP, Duclos-Vallee JC; ANRS C023 CUPILT study group. Sofosbuvir-Based Regimens in HIV/HCV Coinfected Patients After Liver Transplantation: Results From the ANRS CO23 CUPILT Study. Transplantation. 2018 Jan;102(1):119-126. doi: 10.1097/TP.0000000000001928.

Reference Type DERIVED
PMID: 28846559 (View on PubMed)

Leroy V, Dumortier J, Coilly A, Sebagh M, Fougerou-Leurent C, Radenne S, Botta D, Durand F, Silvain C, Lebray P, Houssel-Debry P, Kamar N, D'Alteroche L, Petrov-Sanchez V, Diallo A, Pageaux GP, Duclos-Vallee JC; Agence Nationale de Recherches sur le SIDA et les Hepatites Virales CO23 Compassionate Use of Protease Inhibitors in Viral C in Liver Transplantation Study Group. Efficacy of Sofosbuvir and Daclatasvir in Patients With Fibrosing Cholestatic Hepatitis C After Liver Transplantation. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1993-2001.e1-2. doi: 10.1016/j.cgh.2015.05.030. Epub 2015 Jun 1.

Reference Type DERIVED
PMID: 26044317 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2013-A00941-44

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.