A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer

Lisa R. Hartman; Ildar Nurmeev; Pavel Svirin; Kevin D. Wolter; Jean Li Yan; Darshana Jani; Neil A. Goldenberg; Nancy Sherman

doi:10.1002/pbc.29764

A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer

Lisa R. Hartman, Ildar Nurmeev, Pavel Svirin, Kevin D. Wolter, Jean Li Yan, Darshana Jani, Neil A. Goldenberg, Nancy Sherman

School of Medicine

Research output: Contribution to journal › Article › peer-review

Abstract

Data from registrational trials of pediatric venous thromboembolism (VTE) treatment are sparse, especially among cancer patients. We conducted a prospective, multicenter, open-label trial (NCT00952380) on dose-finding, safety, and efficacy (measured by 90-day risks of clinically relevant bleeding [CRB] and symptomatic recurrent VTE [srVTE]) of twice-daily subcutaneous dalteparin for acute VTE treatment in patients ≤18 years old. Among 38 patients (cancer, n = 26; noncancer, n = 12), median dalteparin dose requirements per kilogram varied with age but not cancer status. Risks of CRB and srVTE were <4% in cancer and noncancer subgroups. Dalteparin is an important FDA-approved treatment for pediatric VTE, particularly with cancer.

Original language	English (US)
Article number	e29764
Journal	Pediatric Blood and Cancer
Volume	69
Issue number	8
DOIs	https://doi.org/10.1002/pbc.29764
State	Published - Aug 2022

Keywords

dalteparin
malignancy
pediatric
thromboembolism
thrombosis

ASJC Scopus subject areas

Hematology
Oncology
Pediatrics, Perinatology, and Child Health

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10.1002/pbc.29764

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title = "A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer",

abstract = "Data from registrational trials of pediatric venous thromboembolism (VTE) treatment are sparse, especially among cancer patients. We conducted a prospective, multicenter, open-label trial (NCT00952380) on dose-finding, safety, and efficacy (measured by 90-day risks of clinically relevant bleeding [CRB] and symptomatic recurrent VTE [srVTE]) of twice-daily subcutaneous dalteparin for acute VTE treatment in patients ≤18 years old. Among 38 patients (cancer, n = 26; noncancer, n = 12), median dalteparin dose requirements per kilogram varied with age but not cancer status. Risks of CRB and srVTE were <4% in cancer and noncancer subgroups. Dalteparin is an important FDA-approved treatment for pediatric VTE, particularly with cancer.",

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note = "Funding Information: The authors thank the patients and their parents/guardians who participated in this study. Medical writing support and editorial support were provided by Paul Hassan, PhD, CMPP, of Engage Scientific Solutions (Horsham, UK) and was funded by Pfizer. This study was sponsored by Pfizer. Publisher Copyright: {\textcopyright} 2022 The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.",

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AU - Yan, Jean Li

AU - Jani, Darshana

AU - Goldenberg, Neil A.

AU - Sherman, Nancy

N1 - Funding Information: The authors thank the patients and their parents/guardians who participated in this study. Medical writing support and editorial support were provided by Paul Hassan, PhD, CMPP, of Engage Scientific Solutions (Horsham, UK) and was funded by Pfizer. This study was sponsored by Pfizer. Publisher Copyright: © 2022 The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.

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N2 - Data from registrational trials of pediatric venous thromboembolism (VTE) treatment are sparse, especially among cancer patients. We conducted a prospective, multicenter, open-label trial (NCT00952380) on dose-finding, safety, and efficacy (measured by 90-day risks of clinically relevant bleeding [CRB] and symptomatic recurrent VTE [srVTE]) of twice-daily subcutaneous dalteparin for acute VTE treatment in patients ≤18 years old. Among 38 patients (cancer, n = 26; noncancer, n = 12), median dalteparin dose requirements per kilogram varied with age but not cancer status. Risks of CRB and srVTE were <4% in cancer and noncancer subgroups. Dalteparin is an important FDA-approved treatment for pediatric VTE, particularly with cancer.

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A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer

Abstract

Keywords

ASJC Scopus subject areas

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