Direct-acting Antivirals and Hepatocellular Carcinoma Recurrence

NCT ID: NCT03197155

Last Updated: 2017-06-23

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

COMPLETED

Total Enrollment

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-06-01

Study Completion Date

2017-03-31

Brief Summary

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

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.

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.

Hepatocellular Carcinoma Hepatitis C Direct Acting Antivirals

Study Design

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

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Direct Acting Antivirals against hepatitis C virus infection

The cohort includes cirrhotic patients infected with HCV and successfully treated for their first history of hepatocellular carcinoma. Some of these patients were treated with direct-acting antivirals for their HCV infection while the others did not receive any direct-acting antivirals treatment during the follow-up period.

Intervention Type DRUG

Eligibility Criteria

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

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.
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.

Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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

Responsibility Role SPONSOR

Other Identifiers

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

69HCL17_0400

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

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