Retrospective Study of Fragmin (dalteparin sodium) in Neonates
Research type
Research Study
Full title
A Retrospective Chart-Review Study to Evaluate the Safety, Effectiveness and Dosing of Dalteparin for Treatment of Venous Thromboembolism (VTE) in Neonates
IRAS ID
288702
Contact name
Elaine Boyle
Contact email
Sponsor organisation
Pfizer
Clinicaltrials.gov Identifier
Pending, EU Post Authorization Study (PAS) register number
Duration of Study in the UK
0 years, 7 months, 31 days
Research summary
Venous Thromboembolism (VTE) is an acute medical condition which requires immediate medical attention. It occurs in both adult and paediatric patients and includes deep vein thrombosis (DVT) and pulmonary embolism (PE). The incidence of VTE in paediatric patients is reported to be low compared with adults (estimated to be 0.07 – 0.49 per 10,000 children). However, higher incidence rates have been observed in specific paediatric populations including hospitalised children, those with central venous catheters (CVCs) and those recovering from a major surgery.
Fragmin (dalteparin sodium) is a low molecular weight heparin (LMWH) initially approved in 1994 by the U.S. Food and Drug Administration (FDA) for prophylaxis and treatment of VTE in adults. In May 2019, Fragmin became the first FDA-approved therapy to treat VTE in paediatric patients aged 1 month and older. This was based on data from a 2018 clinical trial (Priority Review designation by the FDA), due to the urgent need for an approved treatment for VTE in paediatric patients.
The incidence of VTE specifically in neonates (new-born babies aged <28 days old) is low, and treatment with dalteparin has not been formally assessed in this age group.
This non-interventional study (NIS) will collect secondary data (i.e. existing data) from medical records of neonates (patients aged ≤28 days; ≥ 35 weeks gestation) who were treated with Fragmin (dalteparin sodium) for VTE. Data will be collected from medical records dating back to 2010 at paediatric hospitals with demonstrated neonatology expertise. The aim is of the study is to characterise the safety, effectiveness and dosing of dalteparin in this patient population.
This study is designated as a Post-Authorization Safety Study (PASS) and is a post-marketing commitment (PMC) to the FDA. The study will be carried out in up to 10 sites in the UK and is sponsored by Pfizer.
REC name
Wales REC 5
REC reference
21/WA/0341
Date of REC Opinion
7 Oct 2021
REC opinion
Favourable Opinion