Safety of Dabigatran Etexilate in Blood Clot Prevention in Children
Condition: Venous Thromboembolism; Secondary Prevention
MeSH terms: Neoplasm Metastasis; Thromboembolism; Venous Thromboembolism
Intervention: dabigatran etexilate
Intervention description: Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation
Intervention MeSH terms: Dabigatran
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 214.0
Sex: All
Maximum age: 18 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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