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An Open-Label, Single-Arm, Multicenter Pharmacokinetic Study of Intramuscular Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)

2015-05-18 20:22:29 | BioPortfolio

Summary

The purpose of this study is to evaluate the serum asparaginase activity in subjects ages 18 to <40 years with ALL or LBL who have developed a hypersensitivity to native E. coli asparaginase or pegaspargase.

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Acute Lymphoblastic Leukemia (ALL)/Lymphoblastic Lymphoma (LBL)

Intervention

Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)

Location

Hospital of Navarra
Pamplona
Navarra
Spain
31008

Status

Withdrawn

Source

Jazz Pharmaceuticals

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-05-18T20:22:29-0400

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Medical and Biotech [MESH] Definitions

A species of gram-negative, facultatively anaerobic, rod-shaped bacteria that causes vascular wilts on a wide range of plant species. It was formerly named Erwinia chrysanthemi.

A species of gram-negative bacteria, in the genus ERWINIA, causing a necrotic disease of plants.

A hydrolase enzyme that converts L-asparagine and water to L-aspartate and NH3. EC 3.5.1.1.

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