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Clinical Trials in China / NCT05864014
Active, not recruiting Phase 3

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

NCT05864014 · tracked via the Priya Life Science China tracker
Sponsor
Jiangsu HengRui Medicine Co., Ltd.
Phase
Phase 3
Started
2023-04-25
Last updated
2025-04-16

Condition(s) studied

Chemotherapy-Induced Thrombocytopenia

Investigational drug(s) / intervention(s)

Hetrombopag →Hetrombopag plus PlaceboPlacebo

Hetrombopag: Hetrombopag

Hetrombopag plus Placebo: Hetrombopag plus Placebo

Placebo: Placebo

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Men and women, 18-75 years of age; 2. Participant with a histologically or cytologically confirmed solid tumor receiving treatment with chemotherapeutic agents; 3. Participant experienced thrombocytopenia and chemotherapy delay; 4. ECOG performance status 0-1; 5. 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); 6. Adequate renal function; serum creatinine \< 1.5 x ULN or eGFR≤60 ml/min(Cockcroft-Gault) Exclusion Criteria: 1. Participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; 2. Participant has serious bleeding symptoms; 3. History of allergy to the study drug; 4. Participant with HIV; 5. Pregnant or lactating women; 6. Participant has received any experimental therapy within 4 weeks prior to screening 7. Other conditions that may affect participant's safety or trial evaluations per investigator's discretion

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hematology Tumor Research Center of Harbin First Hospital Haerbin Heilongjiang

More Jiangsu HengRui Medicine Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05864014 on ClinicalTrials.gov ↗ ← All trials in China