drugset / Trial / NCT05583838
A Randomized Trial Comparing Optimized rhTPO Treatment With Eltrombopag Treatment in Pre-treated ITP Pts
Phase 4
Completed
157 enrolled
Institute of Hematology & Blood Diseases Hospital, China
Beijing Public Health Foundation · collabFirst Affiliated Hospital of Xinjiang Medical University · collabHenan Cancer Hospital · collabKashgar 1st People's Hospital · collabNorth China University of Science and Technology · collabPeople's Hospital of Xinjiang Uygur Autonomous Region · collabSecond Affiliated Hospital of Guangzhou Medical University · collabSecond Hospital of Shanxi Medical University · collabShaanxi Provincial People's Hospital · collabShenyang Sunshine Pharmaceutical Co., LTD. · collabThe Affiliated Hospital of Inner Mongolia Medical University · collabThe Second Affiliated Hospital of Dalian Medical University · collabThe Second Affiliated Hospital of Harbin Medical University · collabThe Second Affiliated Hospital of Kunming Medical University · collabThe Second Hospital of Hebei Medical University · collabXi'an Central Hospital · collabXijing Hospital · collabYuyao People's Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
TE-ITP study: Compare the efficacy and safety of optimized rhTPO treatment versus Eltrombopag treatment in previously treated primary immune thrombocytopenia patients.
Timeline
- Start
- 2022-11-22
- Primary completion
- 2024-02-28
- Completion
- 2024-07-16
Outcome
Met primary endpoint
paper was 7 days (95% CI 6.0-7.0) in the rhTPO group versus 15 days (95% CI 9.0-25.0) in the eltrombopag group (p < 0.001). PMID 40896456 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Eltrombopag | Small molecule | 25 mg | Oral |
| Comparator | Eltrombopag | Small molecule | 50 mg | Oral |
| Comparator | Eltrombopag | Small molecule | 75 mg | Oral |
| Subject | rhTPO | Protein / enzyme biologic | 300 iu/kg | Subcutaneous |
| Subject | rhTPO | Protein / enzyme biologic | 600 iu/kg | Subcutaneous |