The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
150
For Part A, all participants would receive hetrombopag treatment.
For Part B,participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。
Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.
Time frame: around 6 months.
Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months
Time frame: around 6 months
Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months
Time frame: around 6 months
Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years
Time frame: around 3 years
Part B:No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until Cycle 2 Day 21, around 3 years.
Time frame: around 3 years.
Part B:Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years;
Time frame: around 3 years;
Proportion of participants achieving platelet count ≥100×109/L without the use of rescue therapy within 14 days after initiating the investigational product treatment,around 3 years;
Time frame: around 3 years;
platelet count nadir from Cycle 1 Day 1 until Cycle 2 Day 21, around 3 years;
Time frame: around 3 years;
Proportion of participants free from serious bleeding events, during the treatment period from the initiation of IP treatment until C2D21, around 3 years;
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Time frame: around 3 years;
Proportion of participants with neutropenia during the treatment period from the initiation of IP treatment until Cycle 2 Day 21, around 3 years.
Time frame: around 3 years.
Number of Adverse Events/Serious Adverse Events, safety lab parameters, vital signs, etc within study period, around 3 years.
Time frame: around 3 years.