A Randomized, Multi-Center, Double-Blind, Phase III Study Evaluating the Efficacy and Safety of Hetrombopag Olamine Tablets vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia

Trial status: Authorised Proportion of participants who completed two consecutive on-study chemotherapy cycles without thrombocytopenia-induced modification of any myelosuppressive agent., Proportion of participants achieving PC ≥100×109 /L without the use of rescue therapy within 14 days after initiating the IP treatment (including Day 14), Proportion of participants with at least a single incidence of rescue therapy., Time to rescue therapy free first platelet response of PC ≥100×109/L defined as the interval between the initiation of IP treatment and the first platelet response., Cumulative duration of platelet response of PC ≥100×109/L without the use of rescue therapy., PC nadir from C1D1 until C2D21 (window period: +4 days)., Cumulative duration of severe thrombocytopenia, defined as the number of consecutive days with a PC of ≤50×109/L., Proportion of participants who completed two consecutive on-study chemotherapy cycles without treatment regimen modification., Proportion of participants with all cause events leading to treatment regimen modifications including dose reduction, delay, omission, or discontinuation., Proportion of participants who are free from serious bleeding events, defined as Grade >=2 per the World Health Organization (WHO) bleeding scale, during the treatment period from the initiation of IP treatment until C2D21 (window period: +4 days)., Number and proportion of participants with adverse events (AEs)/serious adverse events (SAEs), safety laboratory parameters, vital signs, etc., Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until C2D21 (window period: +4 days)., Proportion of non-Asian treatment responders who meet the following criteria (Part A only): 1) Platelet count (PC) of 100×109/L within 14 days after initiating the IP treatment (incl. Day 14); 2) Complete two consecutive on-study chemotherapy cycles (C1 and C2) without thrombocytopenia-induced modification of any myelosuppressive agent; 3) No use of any rescue therapy for thrombocytopenia during the treatment period from initiation of IMP treatment until Day 21 of C2 (C2D21; window period:+4d) Part A: PK parameters (e.g., Cmax, AUC0-tau, Cmin) of hetrombopag in non-Asian participants with CIT., Proportion of treatment responders meeting these criteria: 1. Platelet count (PC) ≥100×109 /L within 14 days after initiating IMP treatment (incl Day 14); 2. Complete two consecutive on-study chemotherapy cycles (C1 and C2) without thrombocytopenia-induced modification of any myelosuppressive agent; 3. No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of IP treatment until Day 21 of C2 (C2D21; window period: +4 days).

Proportion of participants who completed two consecutive on-study chemotherapy cycles without thrombocytopenia-induced modification of any myelosuppressive agent., Proportion of participants achieving PC ≥100×109 /L without the use of rescue therapy within 14 days after initiating the IP treatment (including Day 14), Proportion of participants with at least a single incidence of rescue therapy., Time to rescue therapy free first platelet response of PC ≥100×109/L defined as the interval between the initiation of IP treatment and the first platelet response., Cumulative duration of platelet response of PC ≥100×109/L without the use of rescue therapy., PC nadir from C1D1 until C2D21 (window period: +4 days)., Cumulative duration of severe thrombocytopenia, defined as the number of consecutive days with a PC of ≤50×109/L., Proportion of participants who completed two consecutive on-study chemotherapy cycles without treatment regimen modification., Proportion of participants with all cause events leading to treatment regimen modifications including dose reduction, delay, omission, or discontinuation., Proportion of participants who are free from serious bleeding events, defined as Grade >=2 per the World Health Organization (WHO) bleeding scale, during the treatment period from the initiation of IP treatment until C2D21 (window period: +4 days)., Number and proportion of participants with adverse events (AEs)/serious adverse events (SAEs), safety laboratory parameters, vital signs, etc., Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until C2D21 (window period: +4 days)., Proportion of non-Asian treatment responders who meet the following criteria (Part A only): 1) Platelet count (PC) of 100×109/L within 14 days after initiating the IP treatment (incl. Day 14); 2) Complete two consecutive on-study chemotherapy cycles (C1 and C2) without thrombocytopenia-induced modification of any myelosuppressive agent; 3) No use of any rescue therapy for thrombocytopenia during the treatment period from initiation of IMP treatment until Day 21 of C2 (C2D21; window period:+4d)

Age group: 65+ years, 18-64 years Gender: Female, Male Target enrollment: 34 participants