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

NCT02771405 | Completed Phase 3 DMC

• 1 other identifier: 4/2016
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hepatitis C, Chronic; Hepatocellular Carcinoma

Keywords

HCV-HCC-DAAs

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment

  12 weeks after the last dose of study drugs

Secondary Outcomes (2)

• Percentage of participants with virologic failure during treatment or relapse after treatment

  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

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

Study Arms (4)

Sofosbuvir +Ribavirin

EXPERIMENTAL

Sofosbuvir 400 mg/day +ribavirin for 24 weeks

Drug: Sofosbuvir; Drug: Ribavirin

Sofosbuvir+Simeprevir±Ribavirin

EXPERIMENTAL

Sofosbuvir 400 mg/day +Simeprevir 150 mg/day ± ribavirin for 12 weeks

Drug: Sofosbuvir; Drug: Ribavirin; Drug: Simeprevir

Sofosbuvir+Daclatasvir±Ribavirin

EXPERIMENTAL

Sofosbuvir 400 mg/day +Daclatasvir 60 mg/day ± ribavirin for 12 weeks

Drug: Sofosbuvir; Drug: Ribavirin; Drug: daclatasvir

Sofosbuvir+Ledipasvir±Ribavirin

EXPERIMENTAL

Sofosbuvir 400 mg/day +Ledipasvir 90 mg/day ±ribavirin for 12 weeks

Drug: Sofosbuvir; Drug: Ribavirin; Drug: Ledipasvir

Interventions

Sofosbuvir DRUG

Sofosbuvir 400 mg orally once daily

Also known as: Sovaldi®, GS-7977

Sofosbuvir +Ribavirin; Sofosbuvir+Daclatasvir±Ribavirin; Sofosbuvir+Ledipasvir±Ribavirin; Sofosbuvir+Simeprevir±Ribavirin

Ribavirin DRUG

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

Also known as: Copegus®, Rebetol®

Sofosbuvir +Ribavirin; Sofosbuvir+Daclatasvir±Ribavirin; Sofosbuvir+Ledipasvir±Ribavirin; Sofosbuvir+Simeprevir±Ribavirin

Simeprevir DRUG

Simeprevir 150 mg orally once daily

Also known as: Olysio®, TMC435

Sofosbuvir+Simeprevir±Ribavirin

daclatasvir DRUG

Daclatasvir 60 mg orally once daily

Also known as: clatazev®, BMS-790052

Sofosbuvir+Daclatasvir±Ribavirin

Ledipasvir DRUG

Ledipasvir 90 mg orally once daily

Also known as: Co-formulated with Sofosbuvir in one tablet (Harvoni ® )

Sofosbuvir+Ledipasvir±Ribavirin

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Hepatology & Tropical Medicine Research Institute: lead
• Cairo University: collaborator

Study Sites (1)

Amr Maged

Cairo, 11441, Egypt

Location

Related Publications (1)

• 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.

  PMID: 29727383 DERIVED

MeSH Terms

Conditions

Hepatitis C, Chronic; Carcinoma, Hepatocellular

Interventions

Sofosbuvir; Ribavirin; Simeprevir; daclatasvir; ledipasvir; ledipasvir, sofosbuvir drug combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides; Ribonucleosides; Nucleosides; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Gamal Esmat, MD.

  Cairo University

  PRINCIPAL INVESTIGATOR

• 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 DIRECTOR

• Amr Maged

  National Hepatology & Tropical Medicine Research Institute (NHTMRI)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hepatology & Gastroenterology Consultant , Director of HCC Unit

Study Record Dates

• First Submitted: May 6, 2016
• First Posted: May 13, 2016
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: January 1, 2018
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)