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

Phase 3

Completed

• Conditions: Hepatitis C Genotype 4
• Interventions: Drug: Combined Therapy SOF and DCV

• Registration Number: NCT03080415
• Lead Sponsor: Yassin Abdelghaffar Charity Center for Liver Disease and Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-02-22
• Study First Submitted QC: 2017-03-09
• Study First Posted: 2017-03-15
• Study Start: 2017-03-18
• Primary Completion: 2018-02-18
• Study Completion: 2018-05-18
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-03
• Last Update Posted: 2018-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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,..)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combined Therapy SOF and DCV	Combined Therapy SOF and DCV	-

Primary Outcome Measures

Name	Time	Method
Sustained Viral Clearance	At Week 12 after end of treatment.	HCV RNA qPCR will be used to determine if the target of viral clearance has been established. Detection limit of the kit is 12 IU/ml.
Incidence of Treatment Emergent Adverse Events	During the 12 weeks of treatment.	The presence of any adverse effects will be used to characterize this outcome measure.

Trial Locations

Locations (1)

Professor Yassin Abdel Ghaffar Charity Center for Liver Disease and Research; 🇪🇬 Nasr City, Cairo, Egypt