A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
Recruiting now · Phase 3 · Has a placebo group
Conditions studied: Patients With Chemotherapy-Induced Thrombocytopenia
In brief
The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
Key facts
- Study ID
- NCT07286032
- Run by
- Jiangsu HengRui Medicine Co., Ltd.
- People needed
- 150
- Starts
- 2026-04-16
- Expected to finish
- 2029-06-01
- Last updated by the study team
- 2026-07-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Male or female gender, age ≥18 years at screening.
- Histologically or cytologically confirmed solid tumor (e.g., non-small-cell lung carcinoma [NSCLC], breast, ovarian, bladder, pancreatic, gastrointestinal, or colon/colorectal cancer).
- Receiving platinum- and/or gemcitabine-containing chemotherapy regimens on 21-day treatment cycles.
- Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2.
- Life expectancy ≥6 months.
- Signed ICF for voluntary participation in the study and good compliance.
You may not qualify if…
- Hematopoietic diseases other than CIT (e.g., primary immune thrombocytopenia).
- Hematologic malignancies.
- Thrombocytopenia caused by reasons other than chemotherapy, including but not limited to chronic liver disease, hypersplenism, infection, and hemorrhage, within 6 months prior to Study Day 1.
- Untreated brain metastases; or with leptomeningeal metastasis.
- Conditions that require emergent treatment (e.g., superior vena cava syndrome, spinal cord compression).
- Severe cardiovascular disorders or interventions within 6 months
- Have arterial/venous thrombosis within 6 months
- Known bleeding disorders, platelet dysfunction
- Severe haemorrhage during screening
- Acute or uncontrolled hepatitis B\&C infection
- Human immunodeficiency virus (HIV) infection.
Where it is running
- Mid-Florida Hematology & Oncology Centers, P.A. — Orange City, Florida, United States (enrolling)
- AdventHealth Hematology and Oncology Denver Cypress Hematology and Oncology — Denver, Colorado, United States
- Oncology & Hematology Associates of West Broward — Coral Springs, Florida, United States
- Cancer and Blood Specialty Clinic — Los Alamitos, California, United States
- Springfield Clinic — Springfield, Illinois, United States
- Morristown Medical Center — Morristown, New Jersey, United States
- New York Cancer and Blood Specialists One Oncology — Shirley, New York, United States
Full record on ClinicalTrials.gov
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