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Hepatitis C, ChronicPhase 3FRI-STCNCT02771405

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

A Phase 3 study testing Sofosbuvir, Ribavirin and Simeprevir in people with Hepatitis C, Chronic and Hepatocellular Carcinoma, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Sofosbuvir, Ribavirin and Simeprevir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
150 participants
Where
1 siteEgypt
Study dates
Mar 2016to Jan 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Egypt1 site

  • Amr Maged

    Cairo, 11441

Other trials in Egypt

About this study

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

Read the 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
Being tested
Sofosbuvir, Ribavirin, Simeprevir, daclatasvir, Ledipasvir
Keywords
HCV-HCC-DAAs
Medical subject headings
Hepatitis C, Chronic, Carcinoma, Hepatocellular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SofosbuvirDrug

    Also called Sovaldi®, GS-7977

    Sofosbuvir 400 mg orally once daily

  • RibavirinDrug

    Also called Copegus®, Rebetol®

    Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

  • SimeprevirDrug

    Also called Olysio®, TMC435

    Simeprevir 150 mg orally once daily

  • daclatasvirDrug

    Also called clatazev®, BMS-790052

    Daclatasvir 60 mg orally once daily

  • LedipasvirDrug

    Also called Co-formulated with Sofosbuvir in one tablet (Harvoni ® )

    Ledipasvir 90 mg orally once daily

Study groups in NCT02771405
Study groupRoleWhat they receive
Sofosbuvir +RibavirinExperimentalSofosbuvir 400 mg/day +ribavirin for 24 weeks
Receives: Drug: Sofosbuvir; Drug: Ribavirin
Sofosbuvir+Simeprevir±RibavirinExperimentalSofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks
Receives: Drug: Sofosbuvir; Drug: Ribavirin; Drug: Simeprevir
Sofosbuvir+Daclatasvir±RibavirinExperimentalSofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks
Receives: Drug: Sofosbuvir; Drug: Ribavirin; Drug: daclatasvir
Sofosbuvir+Ledipasvir±RibavirinExperimentalSofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks
Receives: Drug: Sofosbuvir; Drug: Ribavirin; Drug: Ledipasvir

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks after the last dose of study drugs

Secondary outcomes (2)

  1. Percentage of participants with virologic failure during treatment or relapse after treatment

    Measured: 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

    Measured: Follow up will be done from baseline for up to 36 months for detection of sustained HCC treatment,tumoral progression or denovo occurrence

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2017
  4. Study completionJan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02771405
Sponsor's protocol ID
4/2016
Acronym
FRI-STC
Status last verified
Apr 2026
First submitted
6 May 2016
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • Hassany M, Elsharkawy A, Maged A, Mehrez M, Asem N, Gomaa A, Mostafa Z, Abbas B, Soliman M, Esmat G. Hepatitis C virus treatment by direct-acting antivirals in successfully treated hepatocellular carcinoma and possible mutual impact. Eur J Gastroenterol Hepatol. 2018 Aug;30(8):876-881. doi: 10.1097/MEG.0000000000001152.

    PubMed 29727383

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sofosbuvir, Ribavirin and Simeprevir in people with Hepatitis C, Chronic and Hepatocellular Carcinoma, run by National Hepatology & Tropical Medicine Research Institute at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (time frame: 12 weeks after the last dose of study drugs). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02771405, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.

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