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Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

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ClinicalTrials.gov Identifier: NCT00952380
Recruitment Status : Recruiting
First Posted : August 6, 2009
Last Update Posted : January 5, 2018
Sponsor:
Information provided by (Responsible Party):

Study Description
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 Design

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 : April 15, 2018
Estimated Study Completion Date : April 15, 2018
Arms and Interventions

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


Outcome Measures

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 ]


Eligibility Criteria

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
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 67 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 Posted: August 6, 2009    Key Record Dates
Last Update Posted: January 5, 2018
Last Verified: January 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: 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