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

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.

Automated summary

This study found that there is a lack of data from registrational trials on pediatric venous thromboembolism (VTE) treatment, especially among cancer patients. Through a prospective trial, the dose-finding, safety, and efficacy of twice-daily subcutaneous dalteparin for acute VTE treatment in children were evaluated. The results demonstrate that dalteparin is an important FDA-approved treatment for pediatric VTE, particularly in cancer patients.