Eight Weeks Sofosbovir/Ledipasvir in HCV Infected Children Aged 4 to 10 Years

• Status: Completed
• Trial end date: 2019-07-02
• Target enrollment: 0
• Participant gender: All

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 treat children aged between 3 and 12 years with half the adult dose of Sofosbuvir/Ledipasvir combination (Heterosofir).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Liver Institute, Egypt
• Treatments: Ledipasvir

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.