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

Yassin Abdelghaffar Charity Center for Liver Disease and Research

Status and phase: Unknown; Phase 4

Conditions: Hepatitis C Genotype 4

Treatments: Drug: Combined therapy LDV and SOF

Study type: Interventional

Funder types: Other

Identifiers

NCT03743727

LDV SOF T 2018

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No 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, ..)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Combined Therapy LDV and SOF

Experimental group

Treatment:

Drug: Combined therapy LDV and SOF