High-dose Use of rhTPO in CIT Patients
NCT03633019 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50
Last updated 2018-10-30
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.
Conditions
Interventions
- DRUG
-
rhTPO
high dose rhTPO ih
Sponsors & Collaborators
-
Shenyang Pharmaceutical University
collaborator OTHER -
First Affiliated Hospital Xi'an Jiaotong University
lead OTHER
Principal Investigators
-
Lingxiao Zhang, doctor · First Affiliated Hospital of Xian Jiaotong University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-28
- Primary Completion
- 2019-11-30
- Completion
- 2020-12-31
Countries
- China
Study Locations
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