Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00481559
Status:
APPROVED_FOR_MARKETING
Last Update Posted:
2014-01-17
First Post:
2007-05-30
Brief Title:
Treatment Protocol of Voraxaze for Patients Experiencing or at Risk of Methotrexate Toxicity
Sponsor:
BTG International Inc
Organization:
BTG International Inc
Study Overview
Official Title:
An Open-Label Treatment Protocol for the Use of Voraxaze as Adjunctive Treatment for Patients Experiencing or at Risk of Methotrexate Toxicity
Status:
APPROVED_FOR_MARKETING
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
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 3128 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 heshe 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 Unitskg 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 hemoperfusiondialysis
Patient eligibility is based on MTX concentrations and laboratory values obtained per standard of care Once an Investigator identifies a potential patient heshe 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 Unitskg 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 hemoperfusiondialysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None