Clinical Study of OP-07 for Delayed Methotrexate Elimination with Methotrexate-Leucovorin Rescue Therapy

JRCT ID: jRCT2051220026

Registered date:25/05/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Subjects with delayed MTX elimination after MTX/LV rescue therapy
• Date of first enrollment: 27/07/2022
• Target sample size: 10
• Study type: Interventional

Intervention(s)

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 at the same dosage and administration as the first time.

Outcome(s)

Primary Outcome

Safety endpoints:Adverse events
Efficacy endpoints:Blood MTX concentration 48 hours after the initial dose of OP-07

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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

Exclude 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

Related Information

• Primary Sponsor: Watanabe Tatsuo