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Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

Last updated on May 11, 2018

FOR MORE INFORMATION
Study Location
Children's Hospital Colorado
Aurora, Colorado, 80045 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Venous Thromboembolism
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
0-18
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
NCT00952380
Pfizer
Completed
Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

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Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients
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.
Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Venous Thromboembolism
Drug: dalteparin
dalteparin subcutaneous injection
Single Arm
Single arm open-label
Intervention: Drug: dalteparin
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
April 15, 2018
April 15, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

Exclusion Criteria:

Sexes Eligible for Study: All
up to 18 Years   (Child, Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Croatia,   Germany,   Norway,   Poland,   Romania,   Russian Federation,   Slovenia,   Spain,   United States
 
 
NCT00952380
FRAG-A001-201
A6301094 ( Other Identifier: Alias Study Number )
No
Not Provided
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
December 2017

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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