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.

• Authors: Lisa R Hartman, Ildar Nurmeev, Pavel Svirin, Kevin D Wolter, Jean Li Yan, Darshana Jani, Neil A Goldenberg, Nancy Sherman
• Journal: Pediatric blood & cancer (Pediatr Blood Cancer) Vol. 69 Issue 8 Pg. e29764 (08 2022) ISSN: 1545-5017 [Electronic] United States
• PMID: 35678616 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't)
• Copyright: © 2022 The Authors. Pediatric Blood & Cancer published by Wiley Periodicals LLC.

Chemical References

• Anticoagulants
• Dalteparin

Topics

• Adolescent
• Anticoagulants (adverse effects)
• Child
• Dalteparin (adverse effects)
• Hemorrhage (chemically induced, drug therapy)
• Humans
• Neoplasms (complications, drug therapy)
• Prospective Studies
• Venous Thromboembolism (drug therapy)