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

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03743727

Enrollment

Registered

2018-11-16

Start date

2018-08-01

Completion date

2019-06-30

Last updated

2018-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Genotype 4

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.

Interventions

DRUGCombined 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).

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

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, ..)

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Egypt

Contacts

Primary ContactMamdouh A. Ahmed

dr.yassinabdelghaffar@gmail.com02-01221707770

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026