drugset / Trial / NCT04954326
A Study Comparing the Blood Levels of Both Pegaspargase (S95014) Formulations (Liquid vs Lyophilized) in the Treatment of Paediatric Patients With Acute Lymphoblastic Leukemia (ALL)
Phase 2
Completed
89 enrolled
Servier
ADIR, a Servier Group company · collabLes Laboratoires Servier (L.L.S), Russia · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to compare the pharmacokinetics (PK) of both lyophilized and liquid S95014 formulations during the induction phase after a single IV dose in newly diagnosed paediatric patients with ALL
Timeline
- Start
- 2021-05-07
- Primary completion
- 2022-05-20
- Completion
- 2022-05-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegaspargase | Protein / enzyme biologic | 2500 unknown | Intravenous |