Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

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. Identifier: NCT00952380
Recruitment Status : Recruiting
First Posted : August 6, 2009
Last Update Posted : March 8, 2018
Information provided by (Responsible Party):

Brief Summary:
Three month treatment of acute VTE with Fragmin in pediatric cancer patients

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: dalteparin Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Three Month Prospective Open Label Study Of Therapy With Fragmin(Registered) (Dalteparin Sodium Injection) In Children With Venous Thromboembolism With Or Without Malignancies
Actual Study Start Date : August 20, 2009
Estimated Primary Completion Date : March 20, 2018
Estimated Study Completion Date : March 20, 2018

Arm Intervention/treatment
Single Arm
Single arm open-label
Drug: dalteparin
dalteparin subcutaneous injection

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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

Inclusion Criteria:

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00952380

Contact: Pfizer Call Center 1-800-718-1021

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Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information:
Responsible Party: Pfizer Identifier: NCT00952380     History of Changes
Other Study ID Numbers: FRAG-A001-201
A6301094 ( Other Identifier: Alias Study Number )
2016‐000394‐21 ( EudraCT Number )
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: March 8, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
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:
URL: http://

Keywords provided by Pfizer:

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin, Low-Molecular-Weight
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action