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Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir

Primary Purpose

Hepatitis C Genotype 4

Status

Unknown status

Phase

Phase 4

Locations

Egypt

Study Type

Interventional

Intervention

Combined therapy LDV and SOF

About this trial

This is an interventional treatment trial for Hepatitis C Genotype 4

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

HCV chronic infection
Treatment naive and treatment experienced (previous interferon treatment)
No cirrhosis or compensated cirrhosis

Exclusion Criteria:

Co-infection with Hepatitis B (HBV)
Other associated chronic liver illness
Patients with history of hematemesis (non-cirrhotic portal hypertension)
Patients with decompensated cirrhosis (as indicated by biopsy, fibroscan)
Patients on drugs known to interact unfavorably (Amioidarone, ..)

Sites / Locations

Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and ResearchRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Combined Therapy LDV and SOF

Arm Description

Outcomes

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events

The presence of any adverse effects will be used to characterize this outcome measure.

Sustained Viral Clearance

HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.

Secondary Outcome Measures

Full Information

NCT ID

NCT03743727

First Posted

November 14, 2018

Last Updated

November 14, 2018

Sponsor

Yassin Abdelghaffar Charity Center for Liver Disease and Research

1. Study Identification

Unique Protocol Identification Number

NCT03743727

Brief Title

Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir

Official Title

The Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2018 (Actual)

Primary Completion Date

March 30, 2019 (Anticipated)

Study Completion Date

June 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yassin Abdelghaffar Charity Center for Liver Disease and Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is an open, uncontrolled study of twenty-five chronic HCV infected patients carried out at Yassin Abdel Ghaffar Charity Center for Liver Disease and Research. The aim of this study is to investigate the safety & efficacy of combined therapy ledipasvir (LDV) and sofosbuvir (SOF) for treating HCV Genotype 4 in children aged 8 to 18. Due to previous positive results in other clinical studies of this drug it is expected that the drug will have high safety and high efficacy. Safety will be measured by checking for adverse effects, while efficacy will be measured by Real-Time Quantitative Polymerase Chain Reaction (qPCR) detecting viral nucleic acids in blood samples.

6. Conditions and Keywords

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

Hepatitis C Genotype 4

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combined Therapy LDV and SOF

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Combined therapy LDV and SOF

Other Intervention Name(s)

ledipasvir and sofosbuvir

Intervention Description

All patients will receive ledipasvir/sofosbuvir fixed dose combination for 12 weeks. Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg). Patients weighing below 35 kg will receive half the adult dose: ledipasvir (45 mg)/sofosbuvir (200 mg).

Primary Outcome Measure Information:

Title

Incidence of Treatment Emergent Adverse Events

Description

The presence of any adverse effects will be used to characterize this outcome measure.

Time Frame

During the 12 weeks of treatment.

Title

Sustained Viral Clearance

Description

HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.

Time Frame

At Week 12 after end of treatment.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

8 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: HCV chronic infection Treatment naive and treatment experienced (previous interferon treatment) No cirrhosis or compensated cirrhosis Exclusion Criteria: Co-infection with Hepatitis B (HBV) Other associated chronic liver illness Patients with history of hematemesis (non-cirrhotic portal hypertension) Patients with decompensated cirrhosis (as indicated by biopsy, fibroscan) Patients on drugs known to interact unfavorably (Amioidarone, ..)

Central Contact Person:

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

Mamdouh A. Ahmed

Phone

02-01221707770

dr.yassinabdelghaffar@gmail.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tawhida Y. Abdel Ghaffar, MD

Organizational Affiliation

Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

Official's Role

Principal Investigator

Facility Information:

Facility Name

Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

City

Nasr City

State/Province

Cairo

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mamdouh A. Ahmed

Phone

02-01221707770

dr.yassinabdelghaffar@gmail.com

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Treatment of Egyptian Hepatitis C Genotype 4 Infected Children and Adolescents With Combined Ledipasvir/Sofosbuvir

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