drugset / Trial / NCT04554056
Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF
RandomizedParallel-groupQuadruple-blindSupportive care
Summary
In the study, subjects will scheduled to undergo four 21-days cycles of chemotherapy treatment. Three group were treated with MW05 300 μg/kg or MW05 500 μg/kg or PEG-rhG-CSF 100 μg/kg on the 3th day of each cycle randomized 1:1:1 . The dose of the experimental drug MW05 in phase III were determined by independent data monitoring committee (IDMC) according to the efficacy and safety of phase II. Subjects were randomly divided into two groups 1:1 to received either MW05 or PEG-rhG-CSF(100 μg/kg) on the 3th day of each chemotherapy cycle.
Timeline
- Start
- 2020-09-21
- Primary completion
- 2022-08-20
- Completion
- 2022-11-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MW05 | Protein / enzyme biologic | 300 ug/kg | Subcutaneous |
| Subject | MW05 | Protein / enzyme biologic | 500 ug/kg | Subcutaneous |
| Comparator | Pegfilgrastim | Protein / enzyme biologic | 100 ug/kg | Subcutaneous |