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Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00952380
First received: August 4, 2009
Last updated: November 1, 2016
Last verified: November 2016

August 4, 2009
November 1, 2016
August 2009
April 2018   (final data collection date for primary outcome measure)
Efficacy [ 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 ] [ 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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00952380 on ClinicalTrials.gov Archive Site
Safety [ 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 ] [ 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 ] [ Designated as safety issue: Yes ]
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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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 2018
April 2018   (final data collection date for primary outcome measure)

Inclusion Criteria:

Exclusion Criteria:

Both
up to 18 Years   (Child, Adult)
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
United States
 
NCT00952380
FRAG-A001-201, A6301094, 2016-000394-21
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2016

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