drugset / Trial / NCT04466137
Phase 3 Study to Evaluate the Safety and Efficacy of YPEG-rhG-CSF in Malignancies Receiving Chemotherapy
Phase 3
Completed
398 enrolled
Xiamen Amoytop Biotech Co., Ltd.
Cancer Institute and Hospital, Chinese Academy of Medical Sciences · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This phase 3 study is aimed to evaluate the safety and efficacy of YPEG-rhG-CSF in reducing the infection manifested by febrile neutropenia in patients with non-myeloid malignancy who receiving Myelosuppressive Chemotherapy which is likely to cause clinically significant febrile neutropenia.
Timeline
- Start
- 2020-10-16
- Primary completion
- 2021-06-24
- Completion
- 2021-09-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pegfilgrastim | Protein / enzyme biologic | 6 mg | — |
| Subject | Telpegfilgrastim | Protein / enzyme biologic | 33 ug/kg | Subcutaneous |
| Subject | Telpegfilgrastim | Protein / enzyme biologic | 2 mg | Subcutaneous |
| Subject | filgrastim | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |