Clinical trial · Interventional
Romiplostim N01 for Chemotherapy-induced Thrombocytopenia
Romiplostim N01 for Chemotherapy-induced Thrombocytopenia in Tumors: a Prospective Multi-center One-arm Study
NCT07063225CI-TRIAL-00092074recruitingPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapy-induced Thrombocytopenia | — | UNRESOLVED | — |
| Romiplostim N01 | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Romiplostim N01 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Romiplostim N01
- description
- 50 enrolled subjects will be picked up to take Romiplostim N01 at the indicated dose.
- interventionNames
- Drug: Romiplostim N01
Primary outcomes (1)
- measure
- Efficiency after 12 weeks of treatment with Romiplostim N01
- timeFrame
- 12 weeks
- description
- The proportion of patients whose platelet count was ≥ 50 × 10\^9/L after 12 weeks (3 months) of treatment with Romiplostim N01.
Secondary outcomes (5)
- measure
- Other efficacy evaluation after 12 weeks of treatment with Romiplostim N01
- timeFrame
- 12 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.