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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03080415

Enrollment

Registered

2017-03-15

Start date

2017-03-18

Completion date

2018-05-18

Last updated

2018-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C Genotype 4

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.

Interventions

DRUGCombined 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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

All of the participants will be receiving combined therapy of sofosbuvir and daclatasvir for 12 weeks.

Eligibility

Sex/Gender

ALL

Age

8 Years to 18 Years

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,..)

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026