Clinical Study of OP-07 for Delayed Methotrexate Elimination with Methotrexate-Leucovorin Rescue Therapy (OP-07-002 study)

Ohara Pharmaceutical Co., Ltd.0 个研究点目标入组 10 人开始时间: 2022年7月27日最近更新: 2024年7月9日

试验速览

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•Patients whose written informed consent to participate in this study has been obtained from the patient or his/her legally authorized representative
•Patients with delayed MTX elimination during MTX-LV rescue therapy. Delayed MTX elimination should be referred to the following blood MTX concentrations as a guide.
•Time elapsed after administration of MTX (24 hours), with or without any signs of acute kidney injury; 50 micro mol/L
•Time elapsed after administration of MTX (42 hours), without any signs of acute kidney injury; >= 5 micro mol/L
•Time elapsed after administration of MTX (42 hours), with any sign of acute kidney injury; >= 1 micro mol/L
•Time elapsed after administration of MTX (48 hours), without any signs of acute kidney injury; >= 2 micro mol/L
•Time elapsed after administration of MTX (48 hours), with any sign of acute kidney injury; >= 0.4 micro mol/L

•1.Patients with a history of serious hypersensitivity to any of the ingredients of OP-07
•2.Any patients for whom the investigator or subinvestigator considered the risks outweighing the benefits of dosing OP-07

Blood MTX concentration

时间窗: 48 hours

48 hours after the initial dose of OP-07

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发起方