NCT02771405

Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: National Hepatology & Tropical Medicine Research Institute · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatitis C, Chronic
• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DRUG	Sofosbuvir	Sofosbuvir 400 mg orally once daily
DRUG	Ribavirin	Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUG	Simeprevir	Simeprevir 150 mg orally once daily
DRUG	daclatasvir	Daclatasvir 60 mg orally once daily
DRUG	Ledipasvir	Ledipasvir 90 mg orally once daily

Timeline

• Start date: 2016-03-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2016-05-13
• Last updated: 2026-04-13

Locations

1 site across 1 country: Egypt