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

Phase 4

• Conditions: Hepatitis C Genotype 4
• Interventions: Drug: Combined therapy LDV and SOF

• Registration Number: NCT03743727
• Lead Sponsor: Yassin Abdelghaffar Charity Center for Liver Disease and Research

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Status Verified: 2018-11
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-14
• Last Update Submitted: 2018-11-14
• Study First Posted: 2018-11-16
• Last Update Posted: 2018-11-16
• Primary Completion: 2019-03-30
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

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, ..)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined Therapy LDV and SOF	Combined therapy LDV and SOF	-

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research; 🇪🇬 Nasr City, Cairo, Egypt