Hetrombopag for the Treatment of Chemotherapy-Induced Thrombocytopenia in Adults With Solid Tumors.

Study Overview
=================
Brief Summary
-----------------
The purpose of current study is to evaluate the efficacy and safety of hetrombopag for the treatment of chemotherapy-induced thrombocytopenia in patients with solid tumors.

Official Title
-----------------
Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Hetrombopag for the Treatment of Chemotherapy-induced Thrombocytopenia in Adults With Solid Tumors.

Conditions
-----------------
Chemotherapy-Induced Thrombocytopenia

Intervention / Treatment
-----------------
* Drug: Hetrombopag
* Drug: Hetrombopag plus Placebo
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women, 18-75 years of age; Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents; Participant experienced thrombocytopenia and chemotherapy delay; ECOG performance status 0-1; Adequate Liver function; aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3.0 x ULN for participants without liver metastases or 5.0 x ULN for participant with liver metastases); Adequate renal function; serum creatinine < 1.5 x ULN or eGFR≤60 ml/min（Cockcroft-Gault） Exclusion Criteria: Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; Participant has serious bleeding symptoms; History of allergy to the study drug; Participant with HIV; Pregnant or lactating women; Participant has received any experimental therapy within 4 weeks prior to screening Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

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

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of treatment responders. |  | Randomization up to 80 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration from the commencement of treatment to a platelet count ≥100×109/L; |  | Randomization up to 30 days | 
| Proportion of subjects who could complete chemotherapy without dose modification and rescue therapy and; |  | Randomization up to 160 days | 
| Proportion of subjects without serious bleeding events; |  | Randomization up to 190 days | 
| Number of adverse events (AEs)/serious adverse events (SAEs) |  | Randomization up to 190 days |