Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06600659
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-12
Brief Title:
A Study to Determine Number of Patients Who Develop High Ammonia Levels After Receiving Recombinant Erwinia Asparaginase
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Pilot Study to Establish Incidence and Characteristics of Patients At Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase
Status:
RECRUITING
Status Verified Date:
2024-09
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 study evaluates the incidence of symptomatic hyperammonemia high ammonia levels in patients being treated with recombinant Erwinia asparaginase
Detailed Description:
PRIMARY OBJECTIVE
I To determine incidence of patients who develop hyperammonemia secondary to recombinant Erwinia asparaginase
II To characterize patients at risk for hyperammonemia secondary to recombinant Erwinia asparaginase
OUTLINE This is an observational study
Patients undergo blood sample collection complete surveys and have their medical records reviewed on study
I To determine incidence of patients who develop hyperammonemia secondary to recombinant Erwinia asparaginase
II To characterize patients at risk for hyperammonemia secondary to recombinant Erwinia asparaginase
OUTLINE This is an observational study
Patients undergo blood sample collection complete surveys and have their medical records reviewed on study
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