NCT05261646

A Clinical Study of Hetrombopag Olamine Tablets in Adults Receiving 21-day Cycles of Chemotherapy for Solid Tumours, Who Are Delayed for at Least 1 Week From Their Scheduled Cycle Because of Chemotherapy-induced Thrombocytopenia

A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Two-Stage Phase Ⅲ Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets in Treatment of Chemotherapy-Induced Thrombocytopenia

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Jiangsu HengRui Medicine Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is aimed to evaluate the efficacy of different doses of hetrombopag compared to placebo, measured by the proportion of subjects that can complete two planned consecutive chemotherapy cycles with no modification of chemotherapy regimen (i.e., delayed start, dose reduction, omission, or discontinuation) because of thrombocytopenia \[platelet count \<100×109/L\], to determine an optimal dose of hetrombopag and to demonstrate its superiority over placebo.

Conditions

• Chemotherapy-Induced Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Hetrombopag	Stage 1： Hetrombopag lower dose； Hetrombopag higher dose Stage 2: Hetrombopag X mg (dose to be determined based on Stage 1 results)
DRUG	Matching placebo	Matching placebo（Stage 1；Stage 2）

Timeline

• Start date: 2022-04-15
• Primary completion: 2025-03-15
• Completion: 2025-12-15
• First posted: 2022-03-02
• Last updated: 2023-09-28

Regulatory

• FDA-regulated drug study