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

Yassin Abdelghaffar Charity Center for Liver Disease and Research

Status and phase: Completed; Phase 3

Conditions: Hepatitis C Genotype 4

Treatments: Drug: Combined Therapy SOF and DCV

Study type: Interventional

Funder types: Other

Identifiers

NCT03080415

DCV SOF T 2017

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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,..)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

40 participants in 1 patient group

Combined Therapy SOF and DCV

Experimental group

Treatment:

Drug: Combined Therapy SOF and DCV