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

• Status: Unknown status
• Trial end date: 2019-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yassin Abdelghaffar Charity Center for Liver Disease and Research
• Treatments: Ledipasvir; Ledipasvir, sofosbuvir drug combination; Sofosbuvir

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, ..)