Hepatitis C, Hepatocellular Carcinoma, Neoplasm Recurrence, Treatment Complication
Conditions
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.
Interventions
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.
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
masking for radiologists who assess HCC recurrence only. Patients and physicians: not masked.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HCC recurrence | 1 year after HCC ablation procedure |
Secondary
| Measure | Time frame |
|---|---|
| changes in Child-Pugh scores over time | 1 year from HCC ablation procedure |
Countries
Egypt
Outcome results
None listed