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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
129
Hetrombopag
Placebo
Najing Bayi Hospital
Nanjing, Jiangsu, China
The proportion of treatment responders.
Time frame: Randomization up to 90 days
Duration from starting treatment to initiating chemotherapy and platelet count ≥100×109/L
Time frame: Randomization up to 30 days
Proportion of subjects who can completion chemotherapy without rescue therapy and dose modification
Time frame: Randomization up to 150 days
Proportion of subjects without serious bleeding event
Time frame: Randomization up to 180 days
Number of subjects with any Adverse Event (AE) or Serious Adverse Event (SAE) graded by the investigator according to National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE), version 5.0
Time frame: Randomization up to 180 days
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