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COMPLETED
NCT07905989
NA

Twelve Weeks Sofosbuvir/Daclatasvir in HCV Infected Children Aged 6-18 Years

Sponsor: National Liver Institute, Egypt

View on ClinicalTrials.gov

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 to 17 years. Younger children are still on the wait list for treatment. The current study aimed to study the efficacy and safety of combined sofosbuvir (SOF)/daclatasvir (DCV) in children with hepatitis C virus infection aged 6-18 years.

Official title: Safety and Efficacy of Sofosbuvir / Daclatasvir in Children With HCV Aged 6-18 Years

Key Details

Gender

All

Age Range

6 Years - 18 Years

Study Type

INTERVENTIONAL

Enrollment

42

Start Date

2023-12-18

Completion Date

2024-07-25

Last Updated

2026-10-30

Healthy Volunteers

No

Interventions

DRUG

Sofosbuvir/Daclatasvir

Patients weighted less than 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (200/30 mg) daily for 12 weeks. Patients weighted more than or equal to 35 kg receive oral daily dose of Sofosbuvir/Daclatasvir (400/60 mg) daily for 12 weeks

Locations (1)

Pediatric Hepatology, Gastroentrology and Nutrition Department, National Liver Institute, Menoufia University

Cairo, Menoufia, Egypt