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Completed

NCT Number: NCT04653818

HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: 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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Communicable Diseases Digestive System Diseases Digestive System Neoplasms Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases Liver Neoplasms Neoplasm Recurrence Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Recurrence Treatment Complication Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alexandria University, Faculty of Medicine

Alexandria, 21131, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Velpatasvir/Sofosbuvir

Drug

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.

Primary outcomes

  1. HCC recurrence

    Time frame: 1 year after HCC ablation procedure

Secondary outcomes

  1. changes in Child-Pugh scores over time

    Time frame: 1 year from HCC ablation procedure

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: RCT

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 4, 2020
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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