Chemotherapy-Induced Thrombocytopenia
Conditions
Brief summary
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.
Interventions
DRUGHetrombopag
Hetrombopag
DRUGPlacebo
Placebo
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Hetrombopag compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women, 18-75 years of age; 2. Participant with a confirmed diagnosis of solid tumor receiving a chemotherapy regimen; 3. Participant experienced thrombocytopenia and chemotherapy delay; 4. ECOG performance status 0-1;
Exclusion criteria
1. Screening and baseline platelet count\< 30×109/L; 2. Participant has experienced thrombocytopenia due to any etiology other than chemotherapy within 6 months of screening; 3. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; 4. Participant has serious bleeding symptoms; 5. Participant has no hepatic metastases, ALT/AST\>3ULN, TBIL\>3ULN; with hepatic metastases, ALT/AST≥5ULN, TBIL≥5ULN; 6. Blood Cr≥1.5ULN or eGFR≤60 ml/min（Cockcroft-Gault）; 7. History of allergy to the study drug; 8. Participant with HIV; 9. Pregnant or lactating women; 10. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of treatment responders. | Randomization up to 90 days |
Secondary
| Measure | 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 |
Countries
China
Outcome results
None listed