ClinicalTrialsFinder
RecruitingPhase 2NCT07063225

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia in Tumors: a Prospective Multi-center One-arm Study

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

50 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

Summary

To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors

Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • 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 Criteria14

  • 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.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGRomiplostim N01

The subjects will receive ropivacaine N01 treatment, with an initial dose of (2-3) µg/kg. When the dose is less than 250 µg, 250 µg (1 vial) can be administered (subcutaneously), once a week. The dose will be increased by (1) µg/kg each week, up to a maximum of 10 µg/kg, until the platelet count reaches ≥ 50 × 10\^9/L. If the platelet count returns to normal, the dose can be reduced according to the platelet level as appropriate.

Locations(1)

Chinese Academy of Medical Science and Blood Disease Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07063225