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Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

This study is currently recruiting participants.
Verified October 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT00952380
First Posted: August 6, 2009
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Pfizer
August 4, 2009
August 6, 2009
October 13, 2017
August 20, 2009
April 15, 2018   (Final data collection date for primary outcome measure)
Efficacy [ Time Frame: 90 Days ]
Efficacy: Thrombus resolution at the end of study or early termination visit will be measured by repeating the same imaging method used at baseline. [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Efficacy: Thrombus resolution at the end of study or early termination visit will be measured by repeating the same imaging method used at baseline. [ Time Frame: 90 Days ]
Complete list of historical versions of study NCT00952380 on ClinicalTrials.gov Archive Site
Safety [ Time Frame: 90 Days ]
Safety Outcomes will consist of major bleeding episodes, recurrent DVT/Pulmonary embolism and unexpected serious adverse events (SAEs). [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Safety Outcomes will consist of major bleeding episodes, recurrent DVT/Pulmonary embolism and unexpected serious adverse events (SAEs). [ Time Frame: 90 Days ]
Not Provided
Not Provided
 
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
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 ClinicalTrials.gov_Inquiries@pfizer.com
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/data_requests
URL: http://
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP