This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Fragmin for the Treatment of Acute VTE in Pediatric Cancer Patients

This study is currently recruiting participants.
See Contacts and Locations
Verified July 2017 by Pfizer
Information provided by (Responsible Party):
Pfizer Identifier:
First received: August 4, 2009
Last updated: July 11, 2017
Last verified: July 2017
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: 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
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.

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

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 identifier: NCT00952380

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

  Show 58 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
Responsible Party: Pfizer Identifier: NCT00952380     History of Changes
Other Study ID Numbers: FRAG-A001-201
A6301094 ( Other Identifier: Alias Study Number )
Study First Received: August 4, 2009
Last Updated: July 11, 2017

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 processed this record on July 26, 2017