Eltrombopag vs. rhTPO to Increase Platelet Level After HSCT

Summary

The primary objective is to compare the efficacy of eltrombopag vs rhTPO in complete response in patients after HSCT in China. This is a post-marketing, interventional, single-center, double-arm, prospective, open-label, non-inferior, randomized controlled study in adult patients with hematopoietic stem cell transplantation in China. Patients will be recruited consecutively from the study sites during the enrollment period. The enrolled patients will be given eltrombopag or rhTPO under the conditions of informed consent and frequent monitoring according to the clinical guideline.

Timeline

Start

2018-07-01

Primary completion

2021-08-02

Completion

2022-07-01

Outcome

Met primary endpoint

paper Eltrombopag was non-inferior to rhTPO in promoting platelet engraftment post allo-HSCT for patients with hematological malignancy. PMID 35554955 ↗

paper The cumulative incidence of platelet engraftment on day 60 after transplantation in eltrombopag group was 86.4% (38/44) compared with 85.4% (41/48) in the rhTPO group (absolute risk difference [ARD] 1%, one-sided lower limit of 95% confidence interval [CI] -13.28%, Pnon-inferirioty = 0.014). PMID 35554955 ↗

Publications

• Wen B, Zhang X, Chen S, Fan J, Yang S, Cai Y, Wang P, Zhang Q, Gu Q, Du X. Oral eltrombopag versus subcutaneous recombinant human thrombopoietin for promoting platelet engraftment after allogeneic stem cell transplantation: A prospective, non-inferiority, randomized controlled trial. Hematol Oncol. 2022 Oct;40(4):777-786. doi: 10.1002/hon.3017. Epub 2022 May 18.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eltrombopag	Small molecule	50 mg	Oral
Comparator	Recombinant Human Thrombopoietin	Protein / enzyme biologic	15000 iu	Subcutaneous

Indications