drugset / Trial / 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

NCT05261646

RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2022-04-15
Primary completion
2025-03-15
Completion
2025-12-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Hetrombopag Small molecule

Indications