NCT07286032 · Jiangsu HengRui Medicine Co., Ltd.
A Study to Evaluate the Efficacy and Safety of Hetrombopag Olamine Tablets Vs Placebo in Patients With Chemotherapy-Induced Thrombocytopenia
What this study is about
The study is being conducted to evaluate the effectiveness, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
View original scientific description
The study is being conducted to evaluate the efficacy, and safety of of Hetrombopag Olamine Tablets Vs Placebo in Patients with Chemotherapy-Induced Thrombocytopenia.
Interventions
DRUG
Hetrombopag Olamine
For Part A, all participants would receive hetrombopag treatment.
DRUG
Hetrombopag Olamine ；Hetrombopag Olamine Placebo
For Part B，participants would be randomized to receive hetrombopag treatment or matching placebo, respectively。
Primary outcome measures
Part A: Cmax of hetrombopag in non-Asian participants with CIT, around 6 months.
Time frame: around 6 months.
Part A: AUC0-tauof hetrombopag in non-Asian participants with CIT, around 6 months
Time frame: around 6 months
Part A: Cmin of hetrombopag in non-Asian participants with CIT, around 6 months
Time frame: around 6 months
Part B:A platelet count of ≥100×109/L within 14 days after initiating the investigational product treatment, around 3 years
Time frame: around 3 years
Part B:No use of any rescue therapy for thrombocytopenia during the treatment period from the initiation of investigational product treatment until Cycle 2 Day 21, around 3 years.
Time frame: around 3 years.
Part B:Complete two consecutive on-study chemotherapy cycles (Cycle 1 and Cycle 2) without thrombocytopenia-induced modification of any myelosuppressive agent, around 3 years;
Time frame: around 3 years;
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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
- Los Alamitos, California
- Denver, Colorado
- Coral Springs, Florida
- Orange City, Florida
- Springfield, Illinois
- Morristown, New Jersey
- Shirley, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations