Back to resultsHCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial (RCT)
Primary Purpose
Hepatocellular Carcinoma, Hepatitis C, Neoplasm Recurrence
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Velpatasvir/Sofosbuvir
Sponsored by
About this trial
This is an interventional other trial for Hepatocellular Carcinoma
Eligibility Criteria
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.
Sites / Locations
- Alexandria University, Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
DAAs group
Postponed DAAs group
Arm Description
Those with complete HCC ablation who will start sofosbuvir / velpatasvir aiming to eradicate HCV.
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.
Outcomes
Primary Outcome Measures
HCC recurrence
Secondary Outcome Measures
changes in Child-Pugh scores over time
Full Information
NCT ID
NCT04653818
First Posted
November 28, 2020
Last Updated
March 31, 2023
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT04653818
Brief Title
HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial
Acronym
RCT
Official Title
Does Directly Acting Antivirals Usage Affect HCV Related Hepatocellular Carcinoma Recurrence After Percutaneous Ablation: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
October 24, 2022 (Actual)
Study Completion Date
October 24, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma, Hepatitis C, Neoplasm Recurrence, Treatment Complication
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
masking for radiologists who assess HCC recurrence only. Patients and physicians: not masked.
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
DAAs group
Arm Type
Active Comparator
Arm Description
Those with complete HCC ablation who will start sofosbuvir / velpatasvir aiming to eradicate HCV.
Arm Title
Postponed DAAs group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Velpatasvir/Sofosbuvir
Intervention Description
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 Outcome Measure Information:
Title
HCC recurrence
Time Frame
1 year after HCC ablation procedure
Secondary Outcome Measure Information:
Title
changes in Child-Pugh scores over time
Time Frame
1 year from HCC ablation procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Kamal, MD, PhD
Organizational Affiliation
Lecturer of Internal Medicine and Hepatology, Faculty of Medicine, Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria University, Faculty of Medicine
City
Alexandria
ZIP/Postal Code
21131
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
HCV Related Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial
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