Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir

• Status: Completed
• Trial end date: 2018-05-18
• Target enrollment: 0
• Participant gender: All

Summary

This is an open, uncontrolled pilot study of thirty 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 sofosbuvir (SOF) and daclatasvir (DCV) 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 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yassin Abdelghaffar Charity Center for Liver Disease and Research
• Collaborators: Egyptian Cure Bank; Egyptian Cure Bank NGO; Society of Friends of Liver Patients in the Arab World (SLPAW)
• Treatments: Sofosbuvir

Criteria

Inclusion Criteria:

1. Age: 8-18 years

2. Sex: both sexes

3. Naïve patients, with chronic HCV infection

Exclusion Criteria:

1. Co-infection with Hepatitis B virus (HBV)

2. Other associated chronic liver illness

3. Cirrhotic patients (as indicated by biopsy, fibroscan(F4)

4. Patients with history of hematemesis (non cirrhotic portal hypertension)

5. Patients on drugs known to interact unfavorably with SOF (Amiodarone,..)