Open Label Study Comparing Efficacy and Safety of Dabigatran Etexilate to Standard of Care in Paediatric Patients With Venous Thromboembolism (VTE)

Inclusion criteria:

- Male or female subjects 0 to less than 18 years of age at the time of informed consent
/ assent

- Documented diagnosis of clinically stable VTE (e.g. DVT, PE, central line thrombosis,
sinus vein thrombosis) per investigator judgment, initially treated (minimum of 5 to 7
days, but not longer than 21 days) with parenteral anticoagulation therapy, such as
unfractionated heparin (UFH) or a low molecular weight heparin (LMWH).

- Clinical indication for at least 3 month of treatment with anticoagulants for the VTE
episode defined under the above inclusion criterion.

- Written informed consent provided by the patient's parent or legal guardian and assent
provided by the patient (if applicable) at the time of informed consent form (ICF)
signature according to local regulations.

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 a medically accepted contraceptive method per local guidelines. Acceptable
methods of birth control must be used in a correct and consistent manner

- Patients in stratum 3 (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 prohibited or restricted medication within one week of the
first dose of study medication other than medication for prior VTE treatment and
P-glycoprotein inhibitors..

- Patients who have received an investigational drug in the past 30 days prior to
screening

- 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

- Patients or parents/legal guardians who are unwilling or unable to undergo or permit
repeat of the baseline imaging tests required to confirm thrombus resolution at study
day 84 (or eEOT, whichever comes first) or in whom repeating such imaging tests at
these pre-specified time points may not be medically in the patient's best interest.
Examples may include unwarranted radiation exposure as a result of a repeat CT scan at
day 84 for a patient with an isolated case of pulmonary embolism evaluated at baseline
solely by a CT scan. In such cases, the baseline radiological assessment (e.g. CT) may
be supplemented with an acceptable non-radiological assessment at baseline (e.g. MRI)
which could then be repeated at day 84 hence alleviating any potential unwarranted
radiation exposure.

- Further exclusion criteria apply