Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any - 18 |
| Updated: | 6/22/2018 |
| Start Date: | August 20, 2009 |
| End Date: | March 20, 2018 |
A Three Month Prospective Open Label Study Of Therapy With Fragmin(Registered) (Dalteparin Sodium Injection) In Children With Venous Thromboembolism With Or Without Malignancies
Three month treatment of acute VTE with Fragmin in pediatric cancer patients
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.
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.
Inclusion Criteria:
Exclusion Criteria:
We found this trial at
18
sites
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Nemours Children's Clinic At Nemours Children’s Clinic, Jacksonville, we've treated every child as we would...
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St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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University of South Florida The University of South Florida is a high-impact, global research university...
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Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Children's Hospital of Michigan Since 1886, the Children's Hospital of Michigan has been dedicated to...
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Texas Children's Hospital Texas Children's Hospital, located in Houston, Texas, is a not-for-profit organization whose...
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