Overview

Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
Participant gender:
Summary
This is a prospective, controlled, open-label, pharmacokinetic study. This study aims at studying the PK of ledipasvir, sofosbuvir, and GS-331007 metabolite in HCV infected children with hematological malignancy. In this study, patients in both treatment groups will receive 12 weeks of treatment with a fixed-dose combination tablet containing 45 mg of ledipasvir and 200 mg of sofosbuvir (LDV/SOF) orally, once daily with food.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Ain Shams University
Collaborator:
Cairo University
Treatments:
Ledipasvir
Ledipasvir, sofosbuvir drug combination
Sofosbuvir