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

Sponsor

Yassin Abdelghaffar Charity Center for Liver Disease and Research (Other)

Overall Status

Unknown status

CT.gov ID

NCT03743727

Collaborator

(none)

Enrollment

Location

Arm

10.9

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Genotype 4	Drug: Combined therapy LDV and SOF	Phase 4

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Aug 1, 2018

Anticipated Primary Completion Date :

Mar 30, 2019

Anticipated Study Completion Date :

Jun 30, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combined Therapy LDV and SOF	Drug: Combined therapy LDV and SOF 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). Other Names: ledipasvir and sofosbuvir

Arm

Intervention/Treatment

Experimental: Combined Therapy LDV and SOF

Drug: Combined therapy LDV and SOF

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).

Other Names:

ledipasvir and sofosbuvir

Outcome Measures

Primary Outcome Measures

Incidence of Treatment Emergent Adverse Events [During the 12 weeks of treatment.]
The presence of any adverse effects will be used to characterize this outcome measure.
Sustained Viral Clearance [At Week 12 after end of treatment.]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

8 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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, ..)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research	Nasr City	Cairo	Egypt

Sponsors and Collaborators

Yassin Abdelghaffar Charity Center for Liver Disease and Research

Investigators

Principal Investigator: Tawhida Y. Abdel Ghaffar, MD, Yassin Abdel Ghaffar Charity Center for Liver Disease and Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Tawhida Yassin Abdel Ghaffar, Professor, Yassin Abdelghaffar Charity Center for Liver Disease and Research

ClinicalTrials.gov Identifier:

NCT03743727

Other Study ID Numbers:

LDV SOF T 2018

First Posted:

Nov 16, 2018

Last Update Posted:

Nov 16, 2018

Last Verified:

Nov 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Ledipasvir, sofosbuvir drug combination

Study Results

No Results Posted as of Nov 16, 2018