Subjects with delayed MTX elimination after MTX/LV rescue therapy
Conditions
Interventions
Administered intravenously as 50 U/kg of OP-07 for 5 minutes.
When the blood MTX concentration at 48 hours after the initial dose is >= 1 micro mol/L, an additional dose of OP-07 can be administered a
Sponsors
Watanabe Tatsuo
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients whose written informed consent to participate in this study has been obtained from the patient or his/her legally authorized representative 2. 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints:Adverse events Efficacy endpoints:Blood MTX concentration 48 hours after the initial dose of OP-07 | — |
Contacts
Public ContactCustomer Consulation Room
Ohara Pharmaceutical Co., Ltd.
Outcome results
None listed