Spots Global Cancer Trial Database for Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
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Trial Identification
Brief Title: Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
Official Title: A THREE MONTH PROSPECTIVE OPEN LABEL STUDY OF THERAPY WITH FRAGMIN(REGISTERED) (DALTEPARIN SODIUM INJECTION) IN CHILDREN WITH VENOUS THROMBOEMBOLISM WITH OR WITHOUT MALIGNANCIES
Study ID: NCT00952380
Conditions
Interventions
Study Description
Brief Summary: Three month treatment of acute VTE with Fragmin in pediatric cancer patients
Detailed Description: Primary study objectives include are to determine the pharmacodynamic (PD) profiles for treatment doses of dalteparin in pediatric subjects of different ages with cancer and venous thromboembolism (VTE), using anti-Xa (Xa) levels and a population PD analysis methodology, and to determine the median dose required to achieve therapeutic anti- Xa levels (0.5 to 1.0 International Units \[IU\]/mL) based on subject age and weight.
Keywords
Eligibility
Minimum Age:
Eligible Ages: CHILD, ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Children's Hospital Colorado, Aurora, Colorado, United States
MedStar Georgetown University Hospital, Washington, District of Columbia, United States
Nemours Children's Clinic, Jacksonville, Florida, United States
Wolfson Children's Hospital, Jacksonville, Florida, United States
Investigational Drug Service Tampa General Hospital, Tampa, Florida, United States
Tampa General Hospital Center of Research Excellence, Tampa, Florida, United States
Tampa General Hospital, Tampa, Florida, United States
University of South Florida, Tampa, Florida, United States
St. Joseph's Children's Hospital of Tampa, Tampa, Florida, United States
Children's Hospital of Michigan, Detroit, Michigan, United States
Children's Mercy Hospitals and Clinics, Kansas City, Missouri, United States
St. Jude Children's Research Hospital, Memphis, Tennessee, United States
El Paso Children's Hospital, El Paso, Texas, United States
Texas Tech University Health Sciences Center El Paso, El Paso, Texas, United States
Texas Children's Cancer and Hematology Centers, Houston, Texas, United States
Texas Children's Hospital Investigational Pharmacy Services, Houston, Texas, United States
Texas Children's Hospital, Houston, Texas, United States
Sykehusapoteket Oslo, Oslo, , Norway
Oslo universitetssykehus HF, Oslo, , Norway
FSBEI HE Kazan SMU of Minzdrav Russia, Kazan, Republic Tatarstan, Russian Federation
SAHI "Children's Republican Clinical Hospital of the Ministry of, Kazan, Republic Tatarstan, Russian Federation
SBHI of Moscow city Morozovskaya Children City Clinical Hospital of Moscow city, Moscow, , Russian Federation
Lekarna, Univerzitetni klinicni center Ljubljana, Ljubljana, , Slovenia
Pediatricna klinika, Univerzitetni Klinicni Center Ljubljana, Ljubljana, , Slovenia
Hospital HM Universitario Monteprincipe Servicio de Farmacia, Boadilla del Monte, Madrid, Spain
Hospital HM Universitario Monteprincipe, Boadilla del Monte, Madrid, Spain
Contact Details
Name: Pfizer CT.gov Call Center
Affiliation: Pfizer
Role: STUDY_DIRECTOR
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