Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Treatment of Blood Clots in Children With Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Eisai Inc.
Information provided by (Responsible Party):
Eisai Inc. Identifier:
First received: August 4, 2009
Last updated: December 20, 2012
Last verified: December 2012

August 4, 2009
December 20, 2012
February 2010
December 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00952380 on Archive Site
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 ]
Same as current
Not Provided
Not Provided
Treatment of Blood Clots in Children With Cancer
A Three Month Prospective Open Label Study Of Therapy With Fragmin (Dalteparin Sodium Injection) In Children With Malignancies And Venous Thromboembolism

The purpose of this study is to determine dosing recommendations when given subcutaneously twice daily along with long term safety information in evaluating thrombus resolution at day 90.

Not Provided
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Venous Thromboembolism
Drug: Fragmin
Subject's age 0-2 months (newborns) will receive an initial dose of 125 IU/kg. Subject's age 2 months to 12 months (infants) will receive an initial dose of 150 IU/kg. Subjects age 12 months through 12 years (preschool and school) will receive an initial dose of 125 IU/kg. Subjects age 12 to 18 years (teen) will receive an initial dose of 100 IU/kg. All subjects will have dose adjustments in 25 IU/kg increments/decrements based upon an anti-Xa therapeutic goal range of 0.5 - 1.0 U/mL.
Other Name: Dalteparin sodium
Experimental: 1
Intervention: Drug: Fragmin
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Have an active malignancy (defined as a diagnosis of cancer, other than basal cell or squamous cell carcinoma of the skin).
  2. Have been objectively diagnosed with thrombosis involving a deep vein (documented using compression ultrasound with Doppler [CUD], computed tomography with/without venography [CT/CTV], magnetic resonance imaging with/without venography [MRI/MRV], conventional venography [CV]) or pulmonary artery (ventilation-perfusion scan [V/Q], spiral CT angiography [SCTA], or conventional pulmonary angiogram [CPA]) within the 96 hours of enrollment, and require anticoagulation therapy.
  3. Are judged clinically to require anticoagulation therapy.
  4. Are in the age range of ≥ 36 weeks gestation and < 19 years.
  5. Have given signed informed consent (and assent, as appropriate) to participate prior to enrollment.

Exclusion Criteria:

  1. Weight ≤ 3.0 kg or > 100 kg.
  2. Platelet count ≤ 50,000/mm3 (despite appropriate medical measures to support platelet count).
  3. Received oral anticoagulant therapy within 72 hours of enrollment.
  4. History of administration of therapeutic doses of LMWH or unfractionated heparin for a treat period of > 96 hours (or > 8 doses of LMWH) for the qualifying VTE.
  5. Received unfractionated heparin within 3 hours, or LMWH within 15 hours of the first dose of dalteparin.
  6. Acute VTE intervention which includes thrombolytic therapy.
  7. Major bleeding at the time of screening or enrollment or an unacceptably high risk of bleeding at the discretion of the investigator.
  8. aPTT > 5 seconds above ULN, and that corrects to within normal limits upon 1:1 mixing with normal plasma.
  9. PT > 2 seconds above ULN, and that corrects to within normal limits upon 1:1 mixing with normal plasma.
  10. Calculated creatinine clearance (Schwartz method) < 60 mL/min in subjects > 1 month of age.
  11. Uncontrolled hypertension characterized by a sustained systolic pressure or diastolic pressure > 99th percentile of age- and height-related norms.
  12. History of heparin-induced thrombocytopenia (HIT).
  13. Any condition in which the investigator feels the subject is unsafe or inappropriate for study participation.
  14. Insufficient subcutaneous tissue to facilitate subcutaneous drug administration.
  15. Presently or previously received (within 30 days of enrollment) study drug for which an IND/IDE is in effect, with the exception of erwinia asparaginase.
  16. Pregnant or lactating female.
  17. Refusal by sexually active post-menarche female subjects to adhere to an acceptable form of contraception.
  18. Unable or unwilling to comply with scheduled follow-up visits.
  19. Inability to obtain written informed consent from subject or parent or legally acceptable representative for the subject.
up to 18 Years
Contact: Martha Kennedy 201-746-2780
Contact: Chad McQueen
United States
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Study Chair: Neil Goldenberg, MD,PhD Univ. of Colorado and The Childrens Hospital
Principal Investigator: Margaret Macy, MD Univ. of Colorado and The Childrens Hospital
Eisai Inc.
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP