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Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

This study is currently recruiting participants.
Verified November 2017 by Pfizer
Sponsor:
ClinicalTrials.gov Identifier:
NCT00952380
First Posted: August 6, 2009
Last Update Posted: November 9, 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
  Purpose
Three month treatment of acute VTE with Fragmin in pediatric cancer patients

Condition Intervention Phase
Venous Thromboembolism Drug: dalteparin Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • 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:
  • 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 ]


Estimated Enrollment: 50
Actual Study Start Date: August 20, 2009
Estimated Study Completion Date: April 15, 2018
Estimated Primary Completion Date: April 15, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single Arm
Single arm open-label
Drug: dalteparin
dalteparin subcutaneous injection

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

Exclusion Criteria:

  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00952380


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Show 66 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00952380     History of Changes
Other Study ID Numbers: FRAG-A001-201
A6301094 ( Other Identifier: Alias Study Number )
First Submitted: August 4, 2009
First Posted: August 6, 2009
Last Update Posted: November 9, 2017
Last Verified: November 2017
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: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/data_requests
URL: http://

Keywords provided by Pfizer:
VTE

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