Safety of Dabigatran Etexilate in Blood Clot Prevention in Children

Completed · Phase 3

Conditions studied: Venous Thromboembolism, Secondary Prevention

In brief

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.

Key facts

Study ID

NCT02197416

Run by

Boehringer Ingelheim

People needed

214

Starts

2014-09-29

Expected to finish

2019-11-19

Last updated by the study team

2020-06-04

Who can join

Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

• 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

Where it is running

• University of Miami — Miami, Florida, United States
• St. Joseph's Children's Hospital — Tampa, Florida, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Alliance for Childhood Diseases — Las Vegas, Nevada, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• University of Virginia Health System — Charlottesville, Virginia, United States
• Providence Sacred Heart Medical Center and Children's Hospital — Spokane, Washington, United States
• AKH - Medical University of Vienna — Vienna, Austria
• Brussels - UNIV UZ Brussel — Brussels, Belgium
• UNIV UZ Gent — Ghent, Belgium
• UZ Leuven — Leuven, Belgium
• HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas — Campinas, Brazil
• Faculdade de Ciencias Medicas da UNICAMP — Campinas, Brazil
• Instituto de Oncologia Pediatrica - IOP / GRAAC - UNIFESP — São Paulo, Brazil
• Kingston General Hospital — Kingston, Ontario, Canada
• CHU Sainte-Justine — Montreal, Ontario, Canada
• Children's Hospital of Eastern Ontario — Ottawa, Ontario, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada
• University Hospital Brno — Brno, Czechia
• University Hospital Olomouc — Olomouc, Czechia
• University Hospital Ostrava — Ostrava, Czechia
• University Hospital Plzen, Plzen-Lochotin — Plzen - Lochotin, Czechia
• University Hospital Motol — Prague, Czechia
• University of California Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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