Article ; Online: A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer.
2022 Volume 69, Issue 8, Page(s) e29764
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 ... ...
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. |
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MeSH term(s) | 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 |
Chemical Substances | Anticoagulants ; Dalteparin (S79O08V79F) |
Language | English |
Publishing date | 2022-06-09 |
Publishing country | United States |
Document type | Clinical Trial, Phase II ; Journal Article ; Multicenter Study ; Research Support, Non-U.S. Gov't |
ZDB-ID | 2131448-2 |
ISSN | 1545-5017 ; 1545-5009 |
ISSN (online) | 1545-5017 |
ISSN | 1545-5009 |
DOI | 10.1002/pbc.29764 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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