Status:
COMPLETED
Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Venous Thromboembolism
Secondary Prevention
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
Brief 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 th...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- 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
- Exclusion criteria:
- Conditions associated with an increased risk of bleeding
- Renal dysfunction (eGFR \< 50 mL/min/1.73m\^2 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
Exclusion
Key Trial Info
Start Date :
September 29 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2019
Estimated Enrollment :
214 Patients enrolled
Trial Details
Trial ID
NCT02197416
Start Date
September 29 2014
End Date
November 19 2019
Last Update
June 4 2020
Active Locations (62)
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1
University of California Davis
Sacramento, California, United States, 95817
2
University of Miami
Miami, Florida, United States, 33136
3
St. Joseph's Children's Hospital
Tampa, Florida, United States, 33607
4
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242-1083