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The study consists of five sequential periods:
Screening (≤ 4 weeks)
Correction phase
Maintenance phase (first treatment cycle, Cycle 1)
Observation phase (second treatment cycle, Cycle 2)
Follow-up Eligible subjects are gynaecological-cancer patients who developed ≥ grade-2 cancer-therapy-induced thrombocytopenia (CTIT) after anti-tumour therapy, i.e. platelet count < 75 × 10⁹/L.
**Cohort 2 (n = 30)** Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. During Cycle 1, monitor PLT closely; if PLT falls < 75 × 10⁹/L, initiate hetrombopag 7.5 mg p.o. daily and continue until C1D21.
**Stage 2** - Prospective, multicentre, randomised, controlled clinical study *(preliminary design; sample size and details will be refined after stage-1 results)* **Experimental arm (n = 92)** Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. Restart within 24 h after completion of Cycle 1 therapy and continue daily until C1D21.
**Control arm (n = 92)** Correction: hetrombopag 7.5 mg p.o. daily until PLT ≥ 100 × 10⁹/L. During Cycle 1, monitor PLT; if PLT < 75 × 10⁹/L, initiate hetrombopag 7.5 mg p.o. daily until C1D21.
**Correction-phase rules** Discontinue hetrombopag once PLT ≥ 100 × 10⁹/L. If after ≥ 14 days of hetrombopag correction PLT remains < 100 × 10⁹/L and the next treatment cycle has not started, the investigator may resume hetrombopag or institute alternative platelet-enhancing rescue therapy at their discretion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Correction phase: start hetrombopag 7.5 mg orally once daily and continue until platelet count norma | Experimental |
| |
| Correction phase: initiate hetrombopag 7.5 mg orally once daily and continue until platelet count re | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hetrombopag 7.5 mg orally once daily | Drug | Correction phase: start hetrombopag 7.5 mg orally once daily and continue until platelet count normalizes (PLT ≥ 100 × 10⁹/L). Within 24 h after completion of Cycle 1 anti-cancer therapy-defined as the end of chemotherapy infusion if on a combined regimen, or the end of study drug administration on that day for non-chemotherapy regimens-restart hetrombopag 7.5 mg orally once daily and maintain until the last day of Cycle 1 (C1D21). |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving a treatment response | Treatment-response criteria (all must be met):
| At the end of the first cycle (each cycle is 28 days). |
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Key eligibility criteria:
Exclusion criteria:
Pregnant or lactating women.
Unable to understand the study nature or give informed consent.
History of any arterial or venous thrombosis (stroke, TIA, MI, DVT, PE) or clinical/laboratory evidence of thrombophilia.
Cardiac disease within 3 months before screening: NYHA class III/IV heart failure, symptomatic arrhythmia requiring therapy, MI, arrhythmias increasing thrombotic risk (e.g., atrial fibrillation), or QTc prolongation.
Thrombocytopenia not related to anti-cancer therapy, active severe bleeding, or refractory persistent thrombocytopenia.
Significant hepatic impairment:
Known or suspected hypersensitivity/intolerance to TPO-receptor agonists or hetrombopag excipients.
Concomitant use of agents that may affect platelet count (e.g., Chinese herbal medicines, other thrombopoietic agents, antiplatelet drugs).
Receipt within 1 month before screening of TPO-RAs (eltrombopag, romiplostim, etc.), rhTPO, or rhIL-11.
Platelet transfusion within 3 days before randomisation/first dose.
Any condition that, in the investigator's opinion, renders the patient unsuitable for the study.
Female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huaiwu Lu | Contact | 02081332587 | luhuaiwu@mail.sysu.edu.cn | |
| Huaiwu Lu | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Huaiwu Lu | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
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|
| ID | Term |
|---|---|
| C000614661 | hetrombopag |
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