Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
NCT ID: NCT00952380
Last Updated: 2019-04-16
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
38 participants
INTERVENTIONAL
2009-08-31
2018-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Single arm open-label
dalteparin
dalteparin subcutaneous injection
Interventions
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dalteparin
dalteparin subcutaneous injection
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Children's Hospital Colorado
Aurora, Colorado, United States
MedStar Georgetown University Hospital
Washington D.C., 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, Russia
SAHI "Children's Republican Clinical Hospital of the Ministry of
Kazan', Republic Tatarstan, Russia
SBHI of Moscow city Morozovskaya Children City Clinical Hospital of Moscow city
Moscow, , Russia
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
Countries
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References
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Hartman LR, Nurmeev I, Svirin P, Wolter KD, Yan JL, Jani D, Goldenberg NA, Sherman N. A phase 2 pharmacodynamic dose-finding, safety, and efficacy study of dalteparin for pediatric venous thromboembolism treatment in children with and without cancer. Pediatr Blood Cancer. 2022 Aug;69(8):e29764. doi: 10.1002/pbc.29764. Epub 2022 Jun 9.
Damle B, Jen F, Sherman N, Jani D, Sweeney K. Population Pharmacokinetic Analysis of Dalteparin in Pediatric Patients With Venous Thromboembolism. J Clin Pharmacol. 2021 Feb;61(2):172-180. doi: 10.1002/jcph.1716. Epub 2020 Aug 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
To obtain contact information for a study center near you, click here.
Other Identifiers
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A6301094
Identifier Type: OTHER
Identifier Source: secondary_id
2016-000394-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
FRAG-A001-201
Identifier Type: -
Identifier Source: org_study_id
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