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

Primary Purpose

Hepatitis C, Chronic, Hepatocellular Carcinoma

Status

Unknown status

Phase

Phase 3

Locations

Egypt

Study Type

Interventional

Intervention

Sofosbuvir

Ribavirin

Simeprevir

daclatasvir

Ledipasvir

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring HCV-HCC-DAAs

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Amr MagedRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Sofosbuvir +Ribavirin

Sofosbuvir+Simeprevir±Ribavirin

Sofosbuvir+Daclatasvir±Ribavirin

Sofosbuvir+Ledipasvir±Ribavirin

Arm Description

Sofosbuvir 400 mg/day +ribavirin for 24 weeks

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

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

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

Outcomes

Primary Outcome Measures

Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment

Secondary Outcome Measures

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

Percentage of Participants who will show any radiological or laboratory changes denoting local or denovo recurrence of HCC

Full Information

NCT ID

NCT02771405

First Posted

May 6, 2016

Last Updated

May 11, 2016

Sponsor

National Hepatology & Tropical Medicine Research Institute

Collaborators

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02771405

Brief Title

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

Acronym

FRI-STC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

February 2019 (Anticipated)

Study Completion Date

September 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

National Hepatology & Tropical Medicine Research Institute

Collaborators

Cairo University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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 : 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatitis C, Chronic, Hepatocellular Carcinoma

Keywords

HCV-HCC-DAAs

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sofosbuvir +Ribavirin

Arm Type

Experimental

Arm Description

Sofosbuvir 400 mg/day +ribavirin for 24 weeks

Arm Title

Sofosbuvir+Simeprevir±Ribavirin

Arm Type

Experimental

Arm Description

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

Arm Title

Sofosbuvir+Daclatasvir±Ribavirin

Arm Type

Experimental

Arm Description

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

Arm Title

Sofosbuvir+Ledipasvir±Ribavirin

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Sofosbuvir

Other Intervention Name(s)

Sovaldi®, GS-7977

Intervention Description

Sofosbuvir 400 mg orally once daily

Intervention Type

Drug

Intervention Name(s)

Ribavirin

Other Intervention Name(s)

Copegus®, Rebetol®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Simeprevir

Other Intervention Name(s)

Olysio®, TMC435

Intervention Description

Simeprevir 150 mg orally once daily

Intervention Type

Drug

Intervention Name(s)

daclatasvir

Other Intervention Name(s)

clatazev®, BMS-790052

Intervention Description

Daclatasvir 60 mg orally once daily

Intervention Type

Drug

Intervention Name(s)

Ledipasvir

Other Intervention Name(s)

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

Intervention Description

Ledipasvir 90 mg orally once daily

Primary Outcome Measure Information:

Title

Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment

Time Frame

12 weeks after the last dose of study drugs

Secondary Outcome Measure Information:

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohamed Hassany, MD.

Phone

+2 01128500015

mohamadhassany@yahoo.com

First Name & Middle Initial & Last Name or Official Title & Degree

Aisha El Sharkawy, MD

Phone

+2 01222211004

a_m_sharkawy@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gamal Esmat, MD.

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Aisha El Sharkawy, MD

Organizational Affiliation

Cairo University

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mohamed Hassany, MD

Organizational Affiliation

National Hepatology & Tropical Medicine Research Institute (NHTMRI)

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Mai Mehrez, MD.

Organizational Affiliation

National Hepatology & Tropical Medicine Research Institute (NHTMRI)

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Amr Maged

Organizational Affiliation

National Hepatology & Tropical Medicine Research Institute (NHTMRI)

Official's Role

Study Chair

Facility Information:

Facility Name

Amr Maged

City

Cairo

ZIP/Postal Code

11441

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amr Maged

amrrasheed88@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

29727383

Citation

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.

Results Reference

derived

Available IPD and Supporting Information:

Available IPD/Information Type

Informed Consent Form

Available IPD/Information URL

http://www.megafileupload.com/f3sT/Attachments_201656.zip

Learn more about this trial

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

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