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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 February 2017 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00952380
First received: August 4, 2009
Last updated: February 14, 2017
Last verified: February 2017
  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: No masking
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
Study Start Date: August 2009
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: April 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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00952380

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 36 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 
Study First Received: August 4, 2009
Last Updated: February 14, 2017

Keywords provided by Pfizer:
VTE

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

ClinicalTrials.gov processed this record on February 20, 2017