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Completed

NCT Number: NCT02771405

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

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

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Key information

Conditions

Hepatitis C, Chronic Adenocarcinoma Blood-Borne Infections Carcinoma Carcinoma, Hepatocellular Chronic Disease Communicable Diseases Digestive System Diseases Digestive System Neoplasms Disease Attributes Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Hepatocellular Carcinoma Infections Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Amr Maged

Cairo, 11441, Egypt

About this study

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 :

  • Sofosbuvir+Ribavirin
  • Sofosbuvir+Simeprevir± Ribavirin
  • Sofosbuvir+ Daclatasvir ± Ribavirin
  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sofosbuvir

Drug

Sofosbuvir 400 mg orally once daily

Other names: Sovaldi®, GS-7977

Ribavirin

Drug

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®

Simeprevir

Drug

Simeprevir 150 mg orally once daily

Other names: Olysio®, TMC435

Daclatasvir

Drug

Daclatasvir 60 mg orally once daily

Other names: clatazev®, BMS-790052

Ledipasvir

Drug

Ledipasvir 90 mg orally once daily

Other names: Co-formulated with Sofosbuvir in one tablet (Harvoni ® )

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment

    Time frame: 12 weeks after the last dose of study drugs

Secondary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

National Hepatology & Tropical Medicine Research Institute

Other Gov

Collaborators

  • Cairo University

Registry information

Acronym: FRI-STC

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
May 13, 2016
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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