Ignite Creation Date:
2025-12-25 @ 3:25 AM
Ignite Modification Date:
2026-03-01 @ 12:04 PM
Study NCT ID:
NCT02771405
Status:
UNKNOWN
Last Update Posted:
2016-05-13
First Post:
2016-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
Sponsor:
National Hepatology & Tropical Medicine Research Institute
Organization:
Study Overview
Official Title:
Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC
Status:
UNKNOWN
Status Verified Date:
2016-05
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FRI-STC
Brief Summary:
The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.
Detailed Description:
The study will recruit 150 patients with HCV related HCC All the studied patients underwent or will undergo one of the curative interventions for HCC either hepatic resection or thermal ablation .
after 1 month of achievement of laboratory and radiological response to HCC intervention the patient will be treated with one of the interferon free regimens :
1. Sofosbuvir+Ribavirin
2. Sofosbuvir+Simeprevir± Ribavirin
3. Sofosbuvir+ Daclatasvir ± Ribavirin
4. Sofosbuvir+ Ledipasvir ± Ribavirin
the treatment duration will be justified either 12 or 24 weeks after treatment the patient will continue on regular follow up to detect HCV cure or recurrence , HCC cure or recurrence and long term follow up of natural history
after 1 month of achievement of laboratory and radiological response to HCC intervention the patient will be treated with one of the interferon free regimens :
1. Sofosbuvir+Ribavirin
2. Sofosbuvir+Simeprevir± Ribavirin
3. Sofosbuvir+ Daclatasvir ± Ribavirin
4. Sofosbuvir+ Ledipasvir ± Ribavirin
the treatment duration will be justified either 12 or 24 weeks after treatment the patient will continue on regular follow up to detect HCV cure or recurrence , HCC cure or recurrence and long term follow up of natural history
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: