Secondary prevention of venous thromboembolism MedDRA version: 17.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865
Conditions
Sponsors
Boehringer Ingeheim RCV GmbH & Co KG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male or female subjects 0 to less than 18 years of age at the time of informed consent / assent and body weight = 40kg - Previously documented objective diagnosis of VTE, followed by completed course of initial VTE treatment (for at least 3 months) or completed study treatment (i.e. reached Visit 8) in the 1160.106 trial - 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. Are the trial subjects under 18? yes Number of subjects for this age range: 100 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
Exclusion criteria: - Conditions associated with an increased risk of bleeding - Renal dysfunction (eGFR 2 × 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 - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety of dabigatran etexilate used for secondary prevention of venous thromboembolism in children from 0 to less than 18 years of age.;Secondary Objective: Not applicable;Primary end point(s): 1: Recurrence of venous thromboembolism (VTE) 2: Major and minor (including clinically relevant non-major (CRNM)) bleeding events 3: Mortality overall and related to thrombotic or thromboembolic events ;Timepoint(s) of evaluation of this end point: 1: 6 and 12 months 2: 6 and 12 months 3: 6 and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Occurrence of post-thrombotic syndrome (PTS) 2: Central measurement of aPTT (Activated partial thromboplastin time) 3: Central measurement of ECT (Ecarin clotting time ) 4: Number of dabigatran etexilate dose adjustments during treatment period ;Timepoint(s) of evaluation of this end point: 1: 6 and 12 months 2: after 3 weeks of treatment 3: after 3 weeks of treatment 4: 12 months | — |
Countries
Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Norway, Russian Federation, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine
Contacts
Public ContactQRPV pSC CT Information Disclosure
Boehringer Ingeheim Pharma GmbH & Co KG
Outcome results
None listed