Pfizer FRAG-A001-201 (A6301094): A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN® (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES
Brief Description
1. To determine the pharmacodynamic (PD) profiles for treatment doses of dalteparin in pediatric subjects of different ages with venous thromboembolism (VTE), and with or without cancer, using anti-Xa (Xa) levels and a population PD analysis methodology
2. To determine the median dose (IU/kg) required to achieve therapeutic anti-Xa levels (0.5 to 1.0 International Units[IU]/mL) based on subject age and weight.
Who may be Eligible
Please contact us for eligibility criteria.
Speciality/Disorder
Ill-Defined Sites
Status
OPEN
Start Date
04/05/2017
Principal Investigator
Hinson, Ashley Rebekah Presar
Contact Name
Gerri Robinson
For More Information, Contact Gerri , Robinson
Phone: 980-442-2355 Fax: Email: gerri.robinson@atriumhealth.org Address:1021 Morehead Medical Drive Suite 2200 Charlotte, 28204