drugset / Trial / NCT03633019
High-dose Use of rhTPO in CIT Patients
Phase 4
Unknown
50 enrolled
First Affiliated Hospital Xi'an Jiaotong University
Shenyang Pharmaceutical University · collab
NaSingle-groupOpen-labelTreatment
Summary
The research studies the safety and efficacy of high-dose recombinant human TPO in solid tumor patients with moderate or severe thrombocytopenia induced by chemotherapy. Patients with platelet count lower than 50 x 109/L will be enrolled and treated with high-dose rhTPO (300-600U/kg/day) until the platelets increased by 50 x 109/L compared to the baseline or above 100 x 109/L. During the study, the blood routine test will be regularly performed according to the clinical routine (at least once every two days). Finally, the clinical data will be collected and analyzed to validate the efficacy and safety of high-dose rhTPO therapy.
Timeline
- Start
- 2018-09-28
- Primary completion
- 2019-11-30
- Completion
- 2020-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | recombinant human thrombopoietin | Protein / enzyme biologic | 300 iu/kg | Other |
| Subject | recombinant human thrombopoietin | Protein / enzyme biologic | 600 iu/kg | Other |