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

Autor: Lisa R. Hartman, Ildar Nurmeev, Pavel Svirin, Kevin D. Wolter, Jean Li Yan, Darshana Jani, Neil A. Goldenberg, Nancy Sherman
Rok vydání: 2022
Předmět:
Zdroj: Pediatric Blood & Cancer. 69
ISSN: 1545-5017
1545-5009
Popis: 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.
Databáze: OpenAIRE
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