Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity
NCT00481559 · Status: APPROVED_FOR_MARKETING · Type: EXPANDED_ACCESS
Last updated 2014-01-17
Summary
This protocol is for the treatment of toxic plasma methotrexate concentrations (\>1 micromole per liter) in patients with delayed methotrexate clearance due to impaired renal function
Conditions
- Neoplasms
Interventions
- DRUG
-
Voraxaze (glucarpidase)
50 Units/kg in a bolus intravenous injection over 5 minutes
Sponsors & Collaborators
-
CTI Clinical Trial and Consulting Services
collaborator OTHER -
BTG International Inc.
lead OTHER
Principal Investigators
-
Paul Litka, MD · BTG (contract)
Eligibility
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
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