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

Pediatr Blood Cancer. 2022 Aug;69(8):e29764. doi: 10.1002/pbc.29764. Epub 2022 Jun 9.

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.

Keywords: dalteparin; malignancy; pediatric; thromboembolism; thrombosis.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Anticoagulants / adverse effects
  • Child
  • Dalteparin / adverse effects
  • Hemorrhage / chemically induced
  • Hemorrhage / drug therapy
  • Humans
  • Neoplasms* / complications
  • Neoplasms* / drug therapy
  • Prospective Studies
  • Venous Thromboembolism* / drug therapy

Substances

  • Anticoagulants
  • Dalteparin

Associated data

  • ClinicalTrials.gov/NCT00952380