Romiplostim N01 for Chemotherapy-induced Thrombocytopenia (NCT07063225) | Clinical Trial Compass
RecruitingPhase 2
Romiplostim N01 for Chemotherapy-induced Thrombocytopenia
China50 participantsStarted 2025-08
Plain-language summary
To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 diseasesï¼›
* 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…
What they're measuring
1
Efficiency after 12 weeks of treatment with Romiplostim N01
Timeframe: 12 weeks
Trial details
NCT IDNCT07063225
SponsorInstitute of Hematology & Blood Diseases Hospital, China