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

Autor: Hartman LR; Children's Hospital Colorado, Aurora, Colorado, USA., Nurmeev I; Kazan State Medical University, Kazan, Russia., Svirin P; Municipal Center of Hemophilia Therapy for Children and Adolescents, Municipal Health Children's Hospital Morozovskaya, Moscow, Russia., Wolter KD; Pfizer Inc, New York, New York, USA., Yan JL; Agenus Bio, Lexington, Massachusetts, USA., Jani D; Pfizer Inc, New York, New York, USA., Goldenberg NA; Departments of Pediatrics and Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.; Johns Hopkins All Children's Cancer and Blood Disorders Institute, Heart Institute, and Institute for Clinical and Translational Research, Johns Hopkins All Children's Hospital, St. Petersburg, Florida, USA., Sherman N; Pfizer Inc, New York, New York, USA.
Jazyk: angličtina
Zdroj: Pediatric blood & cancer [Pediatr Blood Cancer] 2022 Aug; Vol. 69 (8), pp. e29764. Date of Electronic Publication: 2022 Jun 09.
DOI: 10.1002/pbc.29764
Abstrakt: 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.
(© 2022 The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.)
Databáze: MEDLINE
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