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

Sponsor

Alexandria University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04653818

Collaborator

(none)

100

Enrollment

Location

Arms

23.9

Anticipated Duration (Months)

4.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatocellular Carcinoma Hepatitis C Neoplasm Recurrence Treatment Complication	Drug: Velpatasvir/Sofosbuvir	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Oct 5, 2020

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

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.

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

Outcome Measures

Primary Outcome Measures

HCC recurrence [1 year after HCC ablation procedure]

Secondary Outcome Measures

changes in Child-Pugh scores over time [1 year from HCC ablation procedure]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.