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PK of Sofosbuvir/Ledipasvir in HCV-Infected Adolescents with Thalassemia
NCT04353986Phase 3
Key facts
- Status
- Unknown
- Start
- Jun 2018
- Primary completion
- Apr 2023
- Countries
- 1
- Sponsor
- Ain Shams University
- Modality
- Small Molecules
- Drugs
- sofosbuvirledipasvir
- Conditions
- hepatitis C (HCV)
01
Overview
Phase 3, open-label trial of sofosbuvir and ledipasvir in hepatitis C (HCV) (2 arms), sponsored by Ain Shams University. Primary endpoints: Predictive Pharmacokinetic Model at 10 days and Sustained Virologic Response at 6 months. Status: unknown.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Beta thalassemia
HCV infected Beta thalassemia major adolescents receiving SOF/LED
Control
HCV infected, otherwise healthy adolescents receiving SOF/LED
03
Who it enrols
Adolescents (12-18 years) with chronic HCV infection. The experimental group must have beta-thalassemia major, be splenectomized, and receive regular blood transfusions. The control group must be HCV-infected but otherwise healthy. Both groups must be treatment-naive and non-cirrhotic (F0-F3).
04
Endpoints
Primary
Predictive Pharmacokinetic Model
Sustained Virologic Response
Secondary
Adverse Drug Reactions
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