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Romiplostim N01 for Chemotherapy-induced Thrombocytopenia in Tumors: a Prospective Multi-center One-arm Study
To evaluate the efficacy and safety of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia in tumors
The investigator had registered a clinical trial of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia(NCT04600960). Due to the late launch of Romiplostim N01 in China, the investigator also collected the information of Romiplostim N01 in the treatment of chemotherapy-induced thrombocytopenia according to the protocal of Eltrombopag in the treatment of chemotherapy-induced thrombocytopenia(NCT04600960). This is a single-arm study to evaluate the safety and efficacy of Romiplostim N01 to treat chemotherapy-induced thrombocytopenia (CIT)in tumors. These subjects have been treated with recombinant human thrombopoietin(rhTPO) or interleukin 11(IL-11) before, the platelets can rise to normal or reach the effective standard, but after the re-application, the effective standard is not reached, or the effective standard is still not reached after the rhTPO 300U/kg/d treatment for 14 days. The investigator will assess the changes of the platelet counts after the treatment of Romiplostim N01 from week 1 to week 24, and observe incidence of adverse events during the treatment of Romiplostim N01. The investigator will complete the 4 weeks safety visits(once a week),if the subjects end or withdraw from the clinical trial. Patients with chemotherapy-induced thrombocytopenia who had the same inclusion and exclusion criteria in the same period or in the past will be compared with the efficacy and safety of supportive treatment and Eltrombopag in the same period or history, so as to preliminarily explore and evaluate the efficacy and safety of Romiplostim N01 treatment.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Chinese Academy of Medical Science and Blood Disease Hospital
Tianjin, Tianjin Municipality, China
Start Date
August 1, 2025
Primary Completion Date
August 1, 2026
Completion Date
August 1, 2026
Last Updated
July 14, 2025
50
ESTIMATED participants
Romiplostim N01
DRUG
Lead Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Collaborators
NCT05864014
NCT06201663
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06099925