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A Pilot Study to Establish Incidence and Characteristics of Patients at Risk for Symptomatic Hyperammonemia Secondary to Recombinant Erwinia Asparaginase
This study evaluates the incidence of symptomatic hyperammonemia (high ammonia levels) in patients being treated with recombinant Erwinia asparaginase.
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.
Age
1 - No limit years
Sex
ALL
Healthy Volunteers
No
Mayo Clinic in Rochester
Rochester, Minnesota, United States
Start Date
November 2, 2023
Primary Completion Date
December 1, 2026
Completion Date
December 1, 2026
Last Updated
February 6, 2026
10
ESTIMATED participants
Non-Interventional Study
OTHER
Lead Sponsor
Mayo Clinic
NCT02474160
NCT07059884
Data Source & Attribution
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