Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Subjects With Malignancy.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Chemotherapy-Induced Thrombocytopenia

Intervention / Treatment
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* Drug: Hetrombopag
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women, 18-75 years of age; Participant with a confirmed diagnosis of solid tumor receiving a chemotherapy regimen; Participant experienced thrombocytopenia and chemotherapy delay; ECOG performance status 0-1; Exclusion Criteria: Screening and baseline platelet count< 30×109/L; Participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening; Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; Participant has serious bleeding symptoms; Participant has no hepatic metastases, ALT/AST>3ULN, TBIL>3ULN; with hepatic metastases, ALT/AST≥5ULN, TBIL≥5ULN; Blood Cr≥1.5ULN or eGFR≤60 ml/min（Cockcroft-Gault）; History of allergy to the study drug; Participant with HIV; Pregnant or lactating women; Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Hetrombopag compared with placebo
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A：Hetrombopag<br> | Drug: Hetrombopag<br>* Hetrombopag<br>|
| Placebo Comparator: Group B：Placebo<br> | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of treatment responders. |  | Randomization up to 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration from starting treatment to initiating chemotherapy and platelet count ≥100×109/L |  | Randomization up to 30 days | 
| Proportion of subjects who can completion chemotherapy without rescue therapy and dose modification |  | Randomization up to 150 days | 
| Proportion of subjects without serious bleeding event |  | 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 |  | Randomization up to 180 days |