Clinical Study of OP-07 for Delayed Methotrexate Elimination with Methotrexate-Leucovorin Rescue Therapy
- Conditions
- Subjects with delayed MTX elimination after MTX/LV rescue therapy
- Registration Number
- JPRN-jRCT2051220026
- Lead Sponsor
- Watanabe Tatsuo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 10
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/
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety endpoints:Adverse events<br>Efficacy endpoints:Blood MTX concentration 48 hours after the initial dose of OP-07
- Secondary Outcome Measures
Name Time Method