Clinical Research Directory

Safety and Efficacy of Romiplostim in Treatment of Chronic ITP in Children

The aim is to evaluate safety and efficacy of Romiplostim in the treatment of chronic ITP in children

Romiplostim N01 in the Treatment of Thrombocytopenia Caused by Cytotoxic Drugs in Breast Cancer Patients

The primary study objective: To evaluate the efficacy of romiplostim (N01) in the treatment of chemotherapy-induced thrombocytopenia (CIT) in breast cancer patients by assessing the proportion of patients whose platelet count recovers to ≥100×10⁹/L after two weeks of treatment. This study is a multicenter, single-arm, interventional trial. It plans to enroll 68 breast cancer patients with chemotherapy-induced thrombocytopenia (CIT) (PLT \<75×10⁹/L). The study comprises a Screening Period (from after the subject signs the informed consent form until before the first dose), a Treatment Period (including treatment with romiplostim N01), and a Follow-up Period. Screening Period: Subjects will be evaluated against the inclusion and exclusion criteria. Those who qualify may proceed to the Treatment Period. Treatment Period: Eligible subjects from screening will undergo a baseline visit and will receive romiplostim N01 once weekly for a maximum of 4 weeks. Dosing will be stopped when the platelet count increases to ≥100×10⁹/L. When a subject resumes anti-tumor therapy, prophylactic administration of romiplostim N01 (administered 2 hours prior to anti-tumor therapy) will be performed for subjects with a baseline platelet level of \<50×10⁹/L before the administration of the anti-tumor therapy drugs. Dosage Regimen: Romiplostim N01: 200 μg per dose, administered subcutaneously, once weekly. Follow-up Period: Subjects will enter the Follow-up Period after the completion of the treatment.

Romiplostim N01 for Chemotherapy-induced Thrombocytopenia

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