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NCT04653818 Clinical Trial

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

Hepatocellular Carcinoma Clinical Trial

— RCT  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04653818
Other study ID # 0304763
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 5, 2020
Est. completion date October 24, 2022

Study information
Verified date March 2023
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 84
Est. completion date October 24, 2022
Est. primary completion date October 24, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Egypt Alexandria University, Faculty of Medicine Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary HCC recurrence 1 year after HCC ablation procedure
Secondary changes in Child-Pugh scores over time 1 year from HCC ablation procedure
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