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

Phase 4

Completed

• Conditions: Neoplasm Recurrence; Hepatocellular Carcinoma; Hepatitis C; Treatment Complication
• Interventions: Drug: Velpatasvir/Sofosbuvir

• Registration Number: NCT04653818
• Lead Sponsor: Alexandria University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-05
• Study First Submitted: 2020-11-28
• Study First Submitted QC: 2020-11-28
• Study First Posted: 2020-12-04
• Primary Completion: 2022-10-24
• Study Completion: 2022-10-24
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-31
• Last Update Posted: 2023-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 84

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DAAs group	Velpatasvir/Sofosbuvir	Those with complete HCC ablation who will start sofosbuvir / velpatasvir aiming to eradicate HCV.
Postponed DAAs group	Velpatasvir/Sofosbuvir	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.

Primary Outcome Measures

Name	Time	Method
HCC recurrence	1 year after HCC ablation procedure

Secondary Outcome Measures

Name	Time	Method
changes in Child-Pugh scores over time	1 year from HCC ablation procedure

Trial Locations

Locations (1)

Alexandria University, Faculty of Medicine; 🇪🇬 Alexandria, Egypt