drugset / Trial / NCT01663441
A Phase Ⅲa Study of Genetically Modified Recombinant Human Interleukin-11
RandomizedCrossoverSingle-blindPrevention
Summary
This phases Ⅲ trials is divided into two stages,Ⅲa and Ⅲb.The aim of Ⅲa is to evaluate the optimal dosing dose of genetically modified recombinant human IL-11 (mIL-11) in a multicenter randomized self-control trial involving 60 cancer patients undergoing chemotherapy.The aim of Ⅲb is to evaluate the efficacy and safety of genetically modified recombinant human IL-11 (mIL-11), using rhIL-11 as an active control, in a multicenter randomized trial involving 240 cancer patients undergoing chemotherapy.
Timeline
- Start
- 2015-03
- Primary completion
- 2017-08
- Completion
- 2017-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | NL201 | Protein / enzyme biologic | 5 ug/kg | Subcutaneous |
| Comparator | NL201 | Protein / enzyme biologic | 7.5 ug/kg | Subcutaneous |
| Comparator | rhIL-11 | Protein / enzyme biologic | 25 ug/kg | Subcutaneous |