Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00481559|
Recruitment Status : Approved for marketing
First Posted : June 1, 2007
Last Update Posted : January 17, 2014
|First Submitted Date||May 30, 2007|
|First Posted Date||June 1, 2007|
|Last Update Posted Date||January 17, 2014|
|Brief Title||Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity|
|Brief 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|
This treatment protocol will be available on a cost recovery basis to IRB-approved Investigators treating an eligible patient at any site in the US. In order to continue to make Voraxaze™ available following FDA approval and prior to being commercially available. Protherics needs to charge for the product, so there will be a cost to obtain Voraxaze™ under the Open-Label Treatment Protocol. Protherics is permitted under the FDA regulations (21 CFR 312.8) to charge for Voraxaze, to recover those costs associated with its manufacture, research and development, and handling, but do not include other commercial costs (profit).
Patient eligibility is based on MTX concentrations and laboratory values obtained per standard of care. Once an Investigator identifies a potential patient, he/she will contact the Voraxaze central call center (1-877-398-9829) to receive information regarding drug shipment. Eligible patients will have routine demographic, MTX, and Voraxaze therapy information collected.
Each patient will receive a single dose of Voraxaze 50 Units/kg in a bolus intravenous injection over 5 minutes. In addition to Voraxaze, patients will continue to receive standard of care treatment including leucovorin therapy, and supportive care such as hydration, alkalinization of urine and, if necessary, hemoperfusion/dialysis.
|Study Type||Expanded Access|
|Intervention||Drug: Voraxaze (glucarpidase)
50 Units/kg in a bolus intravenous injection over 5 minutes
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Expanded Access Status||Approved for marketing|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||Not Provided|
|Removed Location Countries|
|Responsible Party||BTG International Inc.|
|Study Sponsor||BTG International Inc.|
|Collaborators||CTI Clinical Trial and Consulting Services|
|PRS Account||BTG International Inc.|
|Verification Date||January 2014|