NCT07063225 Romiplostim N01 for Chemotherapy-induced Thrombocytopenia
| NCT ID | NCT07063225 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China |
| Condition | Chemotherapy-induced Thrombocytopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-08 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-08 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
Eligibility Criteria
Inclusion Criteria: * Age: 18 years or above, gender not restricted; * Patients who meet the diagnostic criteria for chemotherapy-related thrombocytopenia, and still ineffective after repeated treatment with rhTPO or IL-11 (subjects need to undergo regular rhTPO treatment for at least 14 days after radiotherapy and chemotherapy, with a dose of rhTPO 300u/kg/d or higher, and the platelet count remains less than 30×10\^9/L, defined as refractory CTIT); * Patients who have stopped chemotherapy and radiotherapy for more than 1 month; * Patients with platelet count at enrollment \< 30×10\^9/L; * Patients with platelet count remains \< 30×10\^9/L for more than 1 month; * Patients with expected survival period ≥ 6 months; * Patients with liver and kidney function \< 1.5× upper limit of normal value, physical examination qualified; * Patients with ECOG physical status score ≤ 2 points; * Patients with Cardiac function: New York Heart Association cardiac function classification is grade 2 or below; * Patients who is voluntary to sign the informed consent form; Exclusion Criteria: * Those with uncontrollable primary diseases of important organs, such as extensive metastasis of malignant tumors, liver failure, heart failure, kidney failure and other diseases； * Patients with poor compliance; * Positive serology for HIV, hepatitis B virus (HBV), hepatitis C virus (HCV), and/or hepatitis D virus (HDV), Syphilis; Positive for Epstein-Barr Virus DNA, Cytomegalovirus DNA; * Accompanied by extensive and severe bleeding, such as hemoptysis, upper gastrointestinal bleeding, intracranial hemorrhage, etc. * There is currently a heart disease requiring treatment or a poorly controlled hypertension judged by the investigator； * Patients with thrombotic diseases such as pulmonary embolism, thrombosis, and atherosclerosis； * Those who have received allogeneic stem cell transplantation or organ transplantation in the past； * Patients with mental disorders who cannot normally obtain informed consent and undergo trials and follow-up； * Patients whose toxic symptoms caused by treatment before participating in the trial have not disappeared； * Other serious diseases that may restrict participants from participating in this trial (such as diabetes; severe heart failure; myocardial obstruction or unstable arrhythmia or unstable angina in the past 6 months; gastric ulcers; mobility Autoimmune diseases, etc.)； * Patients with sepsis or patients with other irregular bleeding； * Patients taking antiplatelet drugs at the same time； * Pregnant women, suspected pregnancy (a positive pregnancy test for human chorionic gonadotropin in urine at screening) and breastfeeding patients； Pre-existing cardiac disease, including congestive heart failure of New York Heart Association \[NYHA\] Grade III/IV, arrhythmia requiring treatment or myocardial infarction within the last 6 months. No arrhythmia known to increase the risk of thrombotic events (e.g. atrial fibrillation), or patients with a QT \>450msec or QTc \> 480 for patients with a Bundle Branch Block; * Researchers believe that patients should not participate in the test of any other condition.
Contact & Investigator
Yunfei Chen, MD
PRINCIPAL INVESTIGATOR
Chinese Academy of Medical Science and Blood Disease Hospital
Frequently Asked Questions
Who can join the NCT07063225 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Chemotherapy-induced Thrombocytopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07063225 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07063225 currently recruiting?
Yes, NCT07063225 is actively recruiting participants. Contact the research team at sunting@ihcams.ac.cn for enrollment information.
Where is the NCT07063225 trial being conducted?
This trial is being conducted at Tianjin, China.
Who is sponsoring the NCT07063225 clinical trial?
NCT07063225 is sponsored by Institute of Hematology & Blood Diseases Hospital, China. The principal investigator is Yunfei Chen, MD at Chinese Academy of Medical Science and Blood Disease Hospital. The trial plans to enroll 50 participants.