drugset / Trial / NCT03903185
Pharmacokinetics of Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancy
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2019-03-01
- Primary completion
- 2023-07-01
- Completion
- 2023-08-15
Publications
- AbdelMagid AM, Abbassi MM, Ebeid FS, El-Sayed MH, Farid SF. Population Pharmacokinetics of Ledipasvir/Sofosbuvir in Pediatric Patients: Impact of Acute Lymphoblastic Leukemia. Clin Ther. 2025 Feb;47(2):e5-e15. doi: 10.1016/j.clinthera.2024.11.022. Epub 2024 Dec 19.
- AbdelMagid AM, Abbassi MM, Ebeid FS, Farid SF, El-Sayed MH. Ledipasvir/Sofosbuvir in Hepatitis C Virus-Infected Children With Hematological Malignancies: A Pharmacokinetic Study. Clin Ther. 2024 Jan;46(1):e12-e22. doi: 10.1016/j.clinthera.2023.10.007. Epub 2023 Nov 3.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ledipasvir/Sofosbuvir | Unknown | 45 mg | Oral |
| Comparator | Ledipasvir/Sofosbuvir | Unknown | 200 mg | Oral |