Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:32 PM
Ignite Modification Date:
2025-12-24 @ 2:32 PM
NCT ID:
NCT00481559
Eligibility Criteria:
Inclusion Criteria:
* Male or female patients of any age who are experiencing delayed MTX clearance due to impaired renal function will be eligible to receive Voraxaze if the have toxic plasma MTX concentrations (\>1 micromole per liter).
Exclusion Criteria:
* Voraxaze is not indicated for use in patients who exhibit the expected clearance of MTX (plasma MTX concentrations within 2 standard deviations of the mean MTX excretion curve specific for the dose of MTX administered) or those with normal or mildly impaired renal function because of the potential risk of sub therapeutic exposure to MTX.
* Patients with known hypersensitivity to Voraxaze (glucarpidase, carboxypeptidases)
Patients intolerant to lactose in food (e.g., dairy products) can still receive Voraxaze.
Sex:
ALL
Study:
NCT00481559
Study Brief:
Protocol Section:
NCT00481559