Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.

Phase 3 Completed 129 enrolled Jiangsu HengRui Medicine Co., Ltd.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

Randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Hetrombopag in subjects with chemotherapy-induced thrombocytopenia receiving chemotherapy for the treatment of solid tumors.

Timeline

Start: 2019-11-06
Primary completion: 2023-02-22
Completion: 2023-02-22

Outcome

Met primary endpoint

paper The proportion of treatment responders was significantly higher in the hetrombopag arm than in the placebo arm [60.7% (17/28) versus 12.9% (4/31); PMID 38882443 ↗

paper p value (nominal) based on the Cochran-Mantel-Haenszel: <0.001 PMID 38882443 ↗

release “NCT03976882）为海曲泊帕治疗CTIT提供了早期随机对照证据，结果显示，海曲泊帕组治疗应答率为60.7%（17/28），显著优于安慰剂组” hengrui.com ↗

Publications

Qin S, Wang Y, Yao J, Liu Y, Yi T, Pan Y, Chen Z, Zhang X, Lu J, Yu J, Zhang Y, Cheng P, Mao Y, Zhang J, Fang M, Zhang Y, Lv J, Li R, Dou N, Tang Q, Ma J. Hetrombopag for the management of chemotherapy-induced thrombocytopenia in patients with advanced solid tumors: a multicenter, randomized, double-blind, placebo-controlled, phase II study. Ther Adv Med Oncol. 2024 Jun 14;16:17588359241260985. doi: 10.1177/17588359241260985. eCollection 2024.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Hetrombopag	Small molecule	7.5 mg	Oral