Symptoms and General Pathology

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Granulocytopenia

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Intravenous(i.v.) administration for one dose. Patients will be randomized to one of three cohorts: 0 mg/kg; 0.5 mg/kg, or 1.0 mg.kg

Intravenous recombinant human mannose binding lectin

Thomas Walsh, MD

The goal of this clinical research study is to find the dose of EZN-2232 that can be given to MBL deficient pediatric cancer patients undergoing chemotherapy. The pharmacokinetics, pharmacodynamics, and safety of the study drug will also be studied.

MBL deficient patients will be randomized in a ratio of 1:1 to receive a single dose of either 0.5 mg/kg or 1.0 mg/kg of intravenous rhMBL. A total of 24 patients will be treated in each of the rhMBL arms, (12 in the 0.5 mg/kg and 12 in the 1.0 mg/kg. All patients are to receive anti-infectious prophylactic supportive therapy as per institutional standards

A Study of Safety, Tolerability, and Pk of rhMBL in Pediatric Hematology/Oncology Pts With Fever and Neutropenia

A Multi-Center Study of the Safety, Tolerability, Pharmacokinetics, and Dose Escalation of Intravenous Recombinant Human Mannose-Binding-Lectin (rhMBL) in MBL Deficient Pediatric Hematology/Oncology Patients With Fever and Neutropenia

Enzon Pharmaceuticals, Inc.

Nazish Huq

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
A Study of Safety, Tolerability, and Pk of rhMBL in Pediatric Hematology/Oncology Pts With Fever and Neutropenia	NCT00520325	Cancer Hematologic Dis... Fever Neutropenia	Intravenous rec... Intravenous rec...	2 Years - 17 Years	Enzon Pharmaceuticals, Inc.
A Study of Safety, Tolerability, and Pk of rhMBL in Pediatric Hematology/Oncology Pts With Fever and Neutropenia	NCT00520325	Cancer Hematologic Dis... Fever Neutropenia	Intravenous rec... Intravenous rec...	2 Years - 17 Years	Enzon Pharmaceuticals, Inc.

Spots Global Cancer Trial Database for mbl deficient oncologic hematologic pediatric fever neutropenia