Trial | NCT03080415  Report issue

Title

Treatment of Egyptian Hepatitis C Genotype 4 Infected Children (and Adolescents) With Combined Sofosbuvir & Daclatasvir
The Safety and Efficacy of Sofosbuvir & Daclatasvir Combined Therapy for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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.
Study Started
Mar 18
2017
Primary Completion
Feb 18
2018
Study Completion
May 18
2018
Last Update
Jun 06
2018

Drug Combined Therapy SOF and DCV

1 whole or half tablet sofosbuvir and 1 whole or half tablet daclatasvir per day SOF dosage: 400 mg/day for greater than 45 kg weight patients; 200 mg/day for 17 kg to 45 kg patients DCV dosage: 60 mg/day for greater than 45 kg weight patients; 30 mg for 17 kg to 45 kg patients

  • Other names: sofosbuvir, daclatasvir

Combined Therapy SOF and DCV Experimental

Criteria 

Inclusion Criteria:

Age: 8-18 years
Sex: both sexes
Naïve patients, with chronic HCV infection

Exclusion Criteria:

Co-infection with Hepatitis B virus (HBV)
Other associated chronic liver illness
Cirrhotic patients (as indicated by biopsy, fibroscan(F4)
Patients with history of hematemesis (non cirrhotic portal hypertension)
Patients on drugs known to interact unfavorably with SOF (Amiodarone,..)
No Results Posted