A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin
NCT06440824 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 60
Last updated 2024-06-04
Summary
A Multicenter Randomized Controlled Study on the Treatment of Refractory CTIT With Romiplostim N01 Compared to Recombinant Human Thrombopoietin
Conditions
- CTIT-Chemotherapy Induced Thrombocytopenia
Interventions
- DRUG
-
Romiplostim N01
2.0 µg/kg, subcutaneous injection, once a week, up to a maximum of 8 weeks. Stop medication when platelet count increases by 50 × 109/L or more compared to before medication
- DRUG
-
Recombinant Human Thrombopoietin
30000 U/d, subcutaneously injected once a day, for a maximum of 8 weeks. Medication should be stopped when platelets increase by 50 × 109/L or more compared to before medication
Sponsors & Collaborators
-
Shandong University
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-01
- Primary Completion
- 2025-06-01
- Completion
- 2025-11-30
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