HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial (RCT)

March 31, 2023 updated by: Ahmed Kamal, Alexandria University

Does Directly Acting Antivirals Usage Affect HCV Related Hepatocellular Carcinoma Recurrence After Percutaneous Ablation: A Randomized Controlled Trial

Data regarding hepatocellular carcinoma (HCC) recurrence after directly acting antivirals (DAAs) given for hepatitis C virus treatment are contradictory. Surprisingly, some studies reported that DAAs are accompanied with higher HCC recurrence. But, other studies showed no rise or even decrease in HCC recurrence. Most of these studies were retrospective and some were non-randomized prospective studies. Here investigators aim to perform a randomized controlled trial to study this issue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 21131
        • Alexandria University, Faculty of Medicine

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

Description

Inclusion Criteria:

  • Child-Pugh A and B subjects with hepatitis C related < 5 cm single or up to 3 hepatocellular carcinomas without any vascular or extrahepatic involvement

Exclusion Criteria:

  • Those with positive HBsAg, history of alcohol consumption, patients with other known causes of chronic liver disease, patients who have received previous DAAs for HCV and patients who have received previous locoregional treatment for HCC will be excluded.

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

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: DAAs group
Those with complete HCC ablation who will start sofosbuvir / velpatasvir aiming to eradicate HCV.
Drug: Velpatasvir/Sofosbuvir
sofosbuvir / velpatasvir will be given for 12 weeks aiming to eradicate HCV. Ribavirin will be added for Child-Pugh B patients or treatment will be extended for 24 weeks for those who are Ribavirin intolerant.
Active Comparator: Postponed DAAs group
Those who will not start DAAs within the 12 months follow up from HCC ablation procedure. Patients of this group will receive DAAs provided that there is no HCC recurrence after the end of 1 year.
Drug: Velpatasvir/Sofosbuvir
sofosbuvir / velpatasvir will be given for 12 weeks aiming to eradicate HCV. Ribavirin will be added for Child-Pugh B patients or treatment will be extended for 24 weeks for those who are Ribavirin intolerant.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HCC recurrence
Time Frame: 1 year after HCC ablation procedure
1 year after HCC ablation procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in Child-Pugh scores over time
Time Frame: 1 year from HCC ablation procedure
1 year from HCC ablation procedure

Collaborators and Investigators

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

Sponsor

Alexandria University

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)

October 5, 2020

Primary Completion (Actual)

October 24, 2022

Study Completion (Actual)

October 24, 2022

Study Registration Dates

First Submitted

November 28, 2020

First Submitted That Met QC Criteria

November 28, 2020

First Posted (Actual)

December 4, 2020

Study Record Updates

Last Update Posted (Actual)

April 4, 2023

Last Update Submitted That Met QC Criteria

March 31, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0304763

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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