Open-Label study of Fragmin in Children with Venous Thromboembolism
Research type
Research Study
Full title
A three month prospective open label study of therapy with Fragmin® (Dalteparin Sodium Injection) in children with venous thromboembolism with or without malignancies
IRAS ID
205251
Contact name
John Grainger
Contact email
Sponsor organisation
Pfizer Inc
Eudract number
2016-000394-21
Clinicaltrials.gov Identifier
79,617, IND number
Duration of Study in the UK
1 years, 7 months, 4 days
Research summary
This is a phase II study to provide information on the conditions under which dalteparin may be used for the acute treatment and secondary preventative treatment of recurrent venous thromboembolism (VTE) in children with or without cancer. The study is being conducted upon request by the US Food and Drug Administration (FDA) for a post-approval study to investigate the safety and efficacy of dalteparin in a paediatric cancer population requiring anticoagulation. This is a 3 month prospective, multicentre, open-label cohort study in approximately 40 centres in North America and Europe to determine twice daily dosing recommendations of dalteparin with respect to age in order to achieve optimum dosing levels. The study is divided into 3 phases: dose adjustment (up to 7 days), Pharmacodynamics (the effects of the drug and how it works in the body over time) and Follow-up (up to 90 days for cancer patients and between 6 weeks – 3 months for non-cancer patients).
Dalteparin sodium is a low molecular weight heparin which is approved for the prevention of deep vein thrombosis in patients undergoing abdominal or hip surgery or in patients with restricted mobility during acute illness. It is also used to prevent complications of heart disease in combination with aspirin. Dalteparin was approved for the extended treatment of VTE in adults with cancer. Research has shown that cancer-associated thrombosis (CAT) is a significant problem which has been poorly recognised and under treated. Cancer patients are more likely to develop VTE and treatment-related bleeding complications. This study will determine the PD and safety profile of dalteparin in paediatric patients (aged under 19) and determine the therapeutic dose based on age and weight. The incidence of bleeding events during dalteparin treatment will also be assessed.REC name
North West - Haydock Research Ethics Committee
REC reference
16/NW/0519
Date of REC Opinion
22 Jul 2016
REC opinion
Favourable Opinion