Open label study comparing efficacy and safety of dabigatran etexilate to standard of care in paediatric patients with VTE

Recruitment & Eligibility

Status: A

Sex: All

Target Recruitment: 360

Inclusion Criteria

- Male or female subjects 0 to less than 18 years of age at the time of informed consent / assent
- Documented diagnosis of VTE per investigator judgment initially treated (generally 5-7 days) with an unfractionated heparin (UFH) or a low molecular weight heparin (LMWH).
- Clinical indication for 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 ICF signature according to local regulations.
Are the trial subjects under 18? yes
Number of subjects for this age range: 270
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Conditions associated with an increased risk of bleeding
- Renal dysfunction (eGFR < 80 mL/min/1.73m2 using the Schwartz formula) or requirement for dialysis
- Active infective endocarditis
- Subjects with a mechanical or a biological heart valve prosthesis
- Hepatic disease:
Active liver disease, including known 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 may include: Intra Uterine Device (IUD); oral, implantable or injectable contraceptives and estrogen patch; double barrier method (spermacide + diaphragm); or abstinence at the discretion of the investigator
- 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.
- 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 days 21 and 84 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 study day 21 and 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 21 and day 84 hence alleviating any potential unwarranted radiation exposure.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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