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

Study Overview
=================
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.

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

Conditions
-----------------
Hepatitis C Genotype 4

Intervention / Treatment
-----------------
* Drug: Combined Therapy SOF and DCV


Participation Criteria
=================
Eligibility 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,..)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All of the participants will be receiving combined therapy of sofosbuvir and daclatasvir for 12 weeks.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combined Therapy SOF and DCV<br> | Drug: Combined Therapy SOF and DCV<br>* 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<br>* Other names: daclatasvir;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment Emergent Adverse Events | The presence of any adverse effects will be used to characterize this outcome measure. | During the 12 weeks of treatment. | 
| Sustained Viral Clearance | 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. | At Week 12 after end of treatment. |