Impact of Interferon Free Regimens in Patients With Chronic HCV and Successfully Treated HCC (FRI-STC)

April 7, 2026 updated by: Mohamed Hassany, National Hepatology & Tropical Medicine Research Institute
The study will recruit 150 patients with HCV related HCC ,after HCC treatment the patients will undergo treatment with different regimens of DAAs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11441
        • Amr Maged

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sofosbuvir +Ribavirin
Sofosbuvir 400 mg/day +ribavirin for 24 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
Drug: Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Names:
  • Copegus®
  • Rebetol®
Experimental: Sofosbuvir+Simeprevir±Ribavirin
Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
Drug: Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Names:
  • Copegus®
  • Rebetol®
Drug: Simeprevir
Simeprevir 150 mg orally once daily
Other Names:
  • Olysio®
  • TMC435
Experimental: Sofosbuvir+Daclatasvir±Ribavirin
Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
Drug: Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Names:
  • Copegus®
  • Rebetol®
Drug: daclatasvir
Daclatasvir 60 mg orally once daily
Other Names:
  • BMS-790052
  • clatazev®
Experimental: Sofosbuvir+Ledipasvir±Ribavirin
Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks
Drug: Sofosbuvir
Sofosbuvir 400 mg orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
Drug: Ribavirin
Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Other Names:
  • Copegus®
  • Rebetol®
Drug: Ledipasvir
Ledipasvir 90 mg orally once daily
Other Names:
  • Co-formulated with Sofosbuvir in one tablet (Harvoni ® )

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment
Time Frame: 12 weeks after the last dose of study drugs
12 weeks after the last dose of study drugs

Secondary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with virologic failure during treatment or relapse after treatment
Time Frame: from baseline until 12 weeks after the last dose of study drugs
from baseline until 12 weeks after the last dose of study drugs
Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC
Time Frame: Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence
Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Hepatology & Tropical Medicine Research Institute

Collaborators

Cairo University

Investigators

  • Principal Investigator: Gamal Esmat, MD., Cairo University
  • Study Director: Aisha El Sharkawy, MD, Cairo University
  • Study Director: Mohamed Hassany, MD, National Hepatology & Tropical Medicine Research Institute (NHTMRI)
  • Study Director: Mai Mehrez, MD., National Hepatology & Tropical Medicine Research Institute (NHTMRI)
  • Study Chair: Amr Maged, National Hepatology & Tropical Medicine Research Institute (NHTMRI)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

January 1, 2018

Study Registration Dates

First Submitted

May 6, 2016

First Submitted That Met QC Criteria

May 11, 2016

First Posted (Estimated)

May 13, 2016

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Informed Consent Form

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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