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

Hepatocellular Carcinoma Clinical Trial

— FRI-STC  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02771405
• Other study ID #: 4/2016
• Status: Recruiting
• Phase: Phase 3
• First received: May 6, 2016
• Last updated: May 11, 2016
• Start date: March 2016
• Est. completion date: September 2019

Study information

• Verified date: May 2016
• Source: National Hepatology & Tropical Medicine Research Institute
• Contact: Mohamed Hassany, MD.
• Phone: +2 01128500015
• Email: mohamadhassany[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial Summary

The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years old

• Confirmed HCV viremia by PCR

• CHILD Pugh "A" or "B7,B8"

• Confirmed HCC either by laboratory ,imaging or histopathological criteria

• Underwent or candidate for curative intervention for HCC (BCLC stage 0 ,A)

• Willing to be treated for HCV and signing informed consent

Exclusion Criteria:

• Patients below 18 or above 70 years old

• patients with advanced liver condition "CHILD score = B9"

• Patients with advanced HCC status (BCLC= B)

• Patients with combined HBV ,HIV infection

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Hepatocellular
• Hepatitis C, Chronic
• Hepatocellular Carcinoma

Intervention

Drug:
• Sofosbuvir
Sofosbuvir 400 mg orally once daily
• Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and = 75 kg = 1200 mg)
• Simeprevir
Simeprevir 150 mg orally once daily
• daclatasvir
Daclatasvir 60 mg orally once daily
• Ledipasvir
Ledipasvir 90 mg orally once daily

Locations

Country	Name	City	State
Egypt	Amr Maged	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
National Hepatology & Tropical Medicine Research Institute	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment		12 weeks after the last dose of study drugs	Yes
Secondary	Percentage of participants with virologic failure during treatment or relapse after treatment		from baseline until 12 weeks after the last dose of study drugs	Yes
Secondary	Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC		Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence	Yes