Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00952380
First received: August 4, 2009
Last updated: July 25, 2016
Last verified: July 2016
  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: Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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 ]


Secondary Outcome Measures:
  • 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 ]


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)
Genders Eligible for Study:   Both
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

Locations
United States, Colorado
The Children's Hospital Terminated
Aurora, Colorado, United States, 80045
United States, District of Columbia
Georgetown University Hospital Terminated
Washington, District of Columbia, United States, 20007
United States, Florida
Nemours Children's Clinic Active, not recruiting
Jacksonville, Florida, United States, 32207
Wolfson Children's Hospital Active, not recruiting
Jacksonville, Florida, United States, 32207
St. Joseph's Children's Hospital of Tampa Active, not recruiting
Tampa, Florida, United States, 33607
United States, Kentucky
Kosair Charities Pediatric, Clinical Research Unit - University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
University of Louisville Health Science Center Recruiting
Louisville, Kentucky, United States, 40202
Kosair Charities Pediatric Clinical Research Unit Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane-Lakeside Hospital for Women and Children Recruiting
Metairie, Louisiana, United States, 70001
Tulane Medical Center Recruiting
New Orleans, Louisiana, United States, 70112
Tulane University School of Medicine Recruiting
New Orleans,, Louisiana, United States, 70112
United States, Michigan
Children's Hospital of Michigan Active, not recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
Children's Mercy Hospitals and Clinics Active, not recruiting
Kansas City, Missouri, United States, 64108
United States, Tennessee
St. Jude Children's Research Hospital Active, not recruiting
Memphis, Tennessee, United States, 38105
United States, Texas
El Paso Children's Hospital Not yet recruiting
El Paso, Texas, United States, 79905
Texas Tech University Health Sciences Center Not yet recruiting
El Paso, Texas, United States, 79905
Texas Children's Cancer and Hematology Centers Terminated
Houston, Texas, United States, 77030
Texas Children's Hospital Investigational Drug Services Terminated
Houston, Texas, United States, 77030
Texas Children's Hospital Terminated
Houston, Texas, United States, 77030
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  2016-000394-21 
Study First Received: August 4, 2009
Last Updated: July 25, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 26, 2016