Status:
COMPLETED
Eight Weeks Sofosbovir/Ledipasvir in HCV Infected Children Aged 4 to 10 Years
Lead Sponsor:
National Liver Institute, Egypt
Conditions:
Hepatitis C, Chronic
Children, Only
Eligibility:
All Genders
3-12 years
Phase:
NA
Brief Summary
Recently the era of direct-acting antiviral drugs for hepatitis C treatment has changed the world map of HCV. Results in adults are promising. FDA approved only two drugs in the pediatric age group 12...
Detailed Description
The WHO has declared hepatitis C a global health problem, with ∼ 3% of the world's population (roughly 170-200 million individuals) infected with HCV. Egypt has the highest prevalence of HCV in the wo...
Eligibility Criteria
Inclusion
- Children with chronic HCV
- age 3- 12 y old
- weight 17- 35kg
- Basal HCV viremia less than 6.8 log IU/mL
- Treatment-naive
- No cirrhosis
Exclusion
- Patients with dual HBV and HCV infection or associated with chronic hepatitis other than chronic HCV
- age below 3 years or above 12 years
- body weight less than 17 or more than 35 Kg
- HCV/HIV coinfection.
- Patients with HCV infection and HCC.
- Patients with HCV infection and underlying cardiac comorbidities
- Decompensated patients with HCV
- Hypoalbuminemia of \< 3.5g/dL.
- International normalised ratio (INR) \>2.
- Advanced fibrosis scoring by transient elastography (F 4 broScan)
- Any concomitant malignancy.
- Parents' refusal for participation of their children in the study.
Key Trial Info
Start Date :
December 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03764345
Start Date
December 6 2018
End Date
July 2 2019
Last Update
September 17 2019
Active Locations (1)
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1
Pediatric Hepatology, Gastroenterology and Nutrition Department, National Liver Institute, Menoufia University
Shebin El-Koom, Menofiya, Egypt, 32511