The Safety and Efficacy of Sofosbuvir & Daclatasvir Combined Therapy for Treatment of Egyptian Children and Adolescents With Chronic Hepatitis C (HCV)-Genotype 4
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sustained Viral Clearance
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,..)
Arms & Interventions
Combined Therapy SOF and DCV
Intervention: Combined Therapy SOF and DCV (Drug)
Outcomes
Primary Outcomes
Sustained Viral Clearance
Time Frame: 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
Time Frame: During the 12 weeks of treatment.
The presence of any adverse effects will be used to characterize this outcome measure.
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. Tawhida Yassin Abdel Ghaffar
Professor
Yassin Abdelghaffar Charity Center for Liver Disease and Research