Study of the Safety and Efficacy of oral Dabigatran Etexilate for the prevention of recurring Venous Thromboembolism

What we are studying

The purpose of this study is to test the safety of the study drug, dabigatran etexilate, in children. You are being asked to take part in this study because you were previously treated for VTE with blood thinning drugs (for at least 3 months) or you have completed the clinical study 1160.106 (The DIVERSITY Study) treatment. In addition, you still have a risk factor for VTE and require further treatment with blood thinning drugs for secondary prevention of VTE. Because this is a research study, dabigatran will be given to you only during this study and not after the study is over.

Who is Eligible

  • Genders:
    • Men
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • All Ages up to 18

Eligibility Criteria

  • Inclusion:
    • Previously documented objective diagnosis of VTE followed by completed course of initial VTE treatment (for at least 3 months) or completed study treatment in the 1160.106 trial
  • Presence of an unresolved clinical risk factor requiring further anticoagulation for secondary VTE prevention (e.g. central venous line; underlying disease; thrombophilia; etc.)
  • Exclusion:
    • Conditions or surgeries (past or future) associated with an increased risk of bleeding
  • Any prior intracranial haemorrhage
  • Intracranial or intraspinal surgeries within 6 months
  • History of intraocular; spinal; retroperitoneal or atraumatic intra-articular bleeding
  • Gastrointestinal haemorrhage within the past year
  • History of gastroduodenal ulcer disease
  • History of haemorrhagic disorder or bleeding diathesis
  • Administration of a fibrinolytic agents within 48 hours of dabigatran etexilate administration
  • Uncontrolled hypertension on antihypertensive medication
  • Any other disease health condition or intervention which in the investigator’s opinion exposes the patient to a higher risk for bleeding
  • Renal dysfunction (eGFR < 80 mL/min)
  • Active infective endocarditis

What is involved

  • Informed consent/assent
  • Medical history/demographics
  • 5X physical examinations
  • 15X vital signs (BP and HR) and weight
  • 4X measure height
  • 4X ECGs
  • 4X pregnancy tests
  • 15X blood draws
  • 1X administration of study drug
  • 10X dispensation of study drug for home use
  • 4X patient treatment assessments (questionnaires).

Compensation

$100.00 each for Visits 1 through Visit 12. The total amount of payment received for completing this study is $1100, as well as $100.00 for each additional (unscheduled) visit.

Contact Information

Study Coordinator
Natalia Dixon
Email
[email protected]
Phone
3367162536

www.all-diplom.com

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Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.