NCT04653818

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P25-P50 for phase_4 hepatocellular-carcinoma

Timeline
Completed

Started Oct 2020

Shorter than P25 for phase_4 hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 5, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 28, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 4, 2020

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 24, 2022

Completed
Last Updated

April 4, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

November 28, 2020

Last Update Submit

March 31, 2023

Conditions

Hepatocellular CarcinomaHepatitis CNeoplasm RecurrenceTreatment Complication

Outcome Measures

Primary Outcomes (1)

  • HCC recurrence

    1 year after HCC ablation procedure

Secondary Outcomes (1)

  • changes in Child-Pugh scores over time

    1 year from HCC ablation procedure

Study Arms (2)

DAAs group

ACTIVE COMPARATOR

Those with complete HCC ablation who will start sofosbuvir / velpatasvir aiming to eradicate HCV.

Drug: Velpatasvir/Sofosbuvir

Postponed DAAs group

ACTIVE COMPARATOR

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

Interventions

Velpatasvir/SofosbuvirDRUG

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.

DAAs groupPostponed DAAs group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University, Faculty of Medicine

Alexandria, 21131, Egypt

Location

Related Publications (1)

  • Kamal A, Metawea M, Omar H, Ghallab M, Kassem A, Naguib H. Hepatitis C Virus-Related One-Year Hepatocellular Carcinoma Recurrence After Directly Acting Antivirals: A Randomized Controlled Trial. J Gastrointest Cancer. 2024 Jun;55(2):913-923. doi: 10.1007/s12029-024-01035-5. Epub 2024 Mar 4.

    PMID: 38436921DERIVED

MeSH Terms

Conditions

Carcinoma, HepatocellularHepatitis CRecurrence

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ahmed Kamal, MD, PhD

    Lecturer of Internal Medicine and Hepatology, Faculty of Medicine, Alexandria University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
masking for radiologists who assess HCC recurrence only. Patients and physicians: not masked.
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

November 28, 2020

First Posted

December 4, 2020

Study Start

October 5, 2020

Primary Completion

October 24, 2022

Study Completion

October 24, 2022

Last Updated

April 4, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Locations

EG(1)