PK of SOF/LED in HCV - Infected Adolescents With Haematological Disorders
Status:
Recruiting
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at
studying the PK of sofosbuvir, ledipasvir and sofosbuvir metabolite (GS-331007) in HCV
infected children with hematological Disorders. to develop predictive pharmacokinetic model
for the 3 moieties in the studied population.
In this study, patients in both treatment groups will receive 12 weeks of treatment with a
fixed-dose combination tablet containing 400 mg of sofosbuvir and 90 mg of
ledipasvir(SOF/LED) orally, once daily with food.
Phase:
Phase 3
Details
Lead Sponsor:
Ain Shams University
Treatments:
Ledipasvir Ledipasvir, sofosbuvir drug combination Sofosbuvir