Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence (RECAR)

June 21, 2017 updated by: Hospices Civils de Lyon

Direct-acting Antiviral Therapy Decreases Hepatocellular Carcinoma Recurrence Rate in Cirrhotic Patients With Chronic Hepatitis C

Background and Aims: Arrival of direct-acting antiviral (DAA) agents against hepatitis C virus (HCV) with high-sustained virological response (SVR) rates and very few side effects has drastically changed the management of HCV infection. The impact of DAA exposure on hepatocellular carcinoma (HCC) recurrence after a first remission in patients with advanced fibrosis remains to be clarified.

Methods: 68 consecutive HCV patients with a first HCC diagnosis and under remission, subsequently treated or not with a DAA combination, were included. Clinical, biological, and virological data were collected at first HCC diagnosis, at remission and during the surveillance period.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

68

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All HCV infected patients from the Department of Hepatology, Croix-Rousse Hospital, Lyon, France developing a first HCC and receiving or not a direct-acting antiviral combination therapy after HCC remission between January 2009 and March 2016 were considered.

Description

Inclusion Criteria:

  • first HCC diagnosed by invasive or non-invasive criteria following the American Association for the Study of Liver Diseases (AASLD) guidelines during the study time horizon
  • complete remission after hepatocellular carcinoma treatment defined by the European Association for the Study of the Liver (EASL) criteria as absence of residual tumor/complete necrosis at imaging one month after the end of hepatocellular carcinoma treatment

Exclusion Criteria:

  • prior history of hepatocellular carcinoma before January 2009
  • liver transplantation before hepatocellular carcinoma diagnosis
  • presence of "non-characterized nodules" after hepatocellular carcinoma treatment at imaging
  • history of direct-acting antivirals treatment before the first hepatocellular carcinoma diagnosis
  • hepatic decompensation
  • human immunodeficiency virus (HIV) coinfection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatocellular recurrence event
Time Frame: From date of HCC remission until the date of HCC recurrence, assessed up to January 1st, 2017
The primary outcome (hepatocellular recurrence event) is evaluated using imaging surveillance data at different time points during follow-up (every 3 months within the first year following HCC remission and every 3 to 6 months thereafter) after the first HCC remission.
From date of HCC remission until the date of HCC recurrence, assessed up to January 1st, 2017

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

January 31, 2017

Study Completion (Actual)

March 31, 2017

Study Registration Dates

First Submitted

June 12, 2017

First Submitted That Met QC Criteria

June 21, 2017

First Posted (Actual)

June 23, 2017

Study Record Updates

Last Update Posted (Actual)

June 23, 2017

Last Update Submitted That Met QC Criteria

June 21, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 69HCL17_0400

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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