Summary

for people ages up to 18 years (full criteria)
at Sacramento, California and other locations
study started
estimated completion

Description

Summary

This open-label, single arm prospective cohort study will assess the safety of dabigatran etexilate in secondary prevention of venous thromboembolism in paediatric patients. Children from 0 to less than 18 years of age will be eligible to participate.

Official Title

Open Label, Single Arm Safety Prospective Cohort Study of Dabigatran Etexilate for Secondary Prevention of Venous Thromboembolism in Children From 0 to Less Than 18 Years

Keywords

Venous Thromboembolism Secondary Prevention Neoplasm Metastasis Thromboembolism Dabigatran dabigatran etexilate

Eligibility

You can join if…

Open to people ages up to 18 years

  • Male or female subjects 0 to less than 18 years of age at the time of informed consent / assent
  • Previously documented objective diagnosis of VTE, followed by completed course of initial VTE treatment for at least 3 months (in case of VKA - intended INR between 2 and 3) or completed study treatment (i.e. reached Visit 8) in the 1160.106 trial. Patients, who during the treatment phase of 1160.106 trial were switched from dabigatran etexilate to SOC arm for any reason, are not eligible for this study.
  • Presence of an unresolved clinical risk factor requiring further anticoagulation for secondary VTE prevention (e.g. central venous line, underlying disease, thrombophilia, etc.)
  • Written informed consent form (ICF) provided by the patient's parent or legal guardian and assent provided by the patient (if applicable) at the time of ICF signature according to local regulations.
  • Further inclusion criteria apply

You CAN'T join if...

  • Conditions associated with an increased risk of bleeding
  • Renal dysfunction (eGFR < 50 mL/min/1.73m2 using the Schwartz formula) or requirement for dialysis. eGFR retesting during the screening period is allowed (once).

  • Active infective endocarditis
  • Subjects with a heart valve prosthesis requiring anticoagulation.
  • Hepatic disease: Active liver disease, including known active hepatitis A, B or C or Persistent alanine aminotransferase (ALT) or aspartate transaminase (AST) or alkaline phosphatase (AP) > 3 × upper limit of normal (ULN) within 3 months of screening
  • Pregnant or breast feeding females. Females who have reached menarche and are not using an acceptable method of birth control, or do not plan to continue using this method throughout the study and / or do not agree to adhere to pregnancy testing required by this protocol
  • Patients in age group 0 to < 2 years with gestational age at birth < 37 weeks or with body weight lower than the 3rd percentile
  • Anemia (hemoglobin < 80g/L) or thrombocytopenia (platelet count < 80 x 109/L) at screening. Transfusions during the screening period are allowed, provided that a satisfactory hemoglobin or platelet level is attained prior to visit 2
  • Patients who have taken restricted medication prior to first dose of study medication
  • Patients who have received an investigational drug in the past 30 days prior to screening, except patients who have completed the treatment period (up to Visit 8) in 1160.106 trial
  • Patients who are allergic/sensitive to any component of the study medication including solvent
  • Patients or parents/legal guardians considered unreliable to participate in the trial per investigator judgment or any condition which would present a safety hazard to the patient based on investigator judgment
  • Further exclusion criteria apply

Locations

  • University of California Davis
    Sacramento California 95817 United States
  • Alliance for Childhood Diseases
    Las Vegas Nevada 89135 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Boehringer Ingelheim
Links
Sign up for this study
ID
NCT02197416
Phase
Phase 3
Study Type
Interventional
Last Updated