MedDRA version: 18.1 Level: LLT Classification code 10066899 Term: Venous thromboembolism System Organ Class: 100000004866 MedDRA version: 18.1 Level: LLT Classification code 10049909 Term: Venous thromboembolism prophylaxis System Organ Class: 100000004865
Conditions
Interventions
Trade Name: Praxbind
Product Name: idarucizumab
Product Code: BI 655075
Pharmaceutical Form: Solution for injection/infusion
INN or Prop
Sponsors
Boehringer Ingelheim AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients taking dabigatran etexilate in the paediatric trials 1160.106 or 1160.108 are eligible for this trial if they meet the following criteria: Group A: - Overt bleeding judged by the treating physician to require a reversal agent. - Currently taking dabigatran etexilate in the context of a clinical trial with dabigatran etexilate (1160.106 or 1160.108). - Male or female patients from 0 to less than 18 years of age at the time of informed consent/assent for participation in trial 1160.106 or in trial 1160.108. - Female patients of childbearing potential (defined as having experienced menarche) must have followed the contraception requirements according to the dabigatran trial 1160.106 or trial 1160.108 in which they are enrolled. - Written informed consent provided by the patient (and/or the patient¿s legally accepted representative) and assent provided by the patient (if applicable) at the time of informed consent signature in accordance with GCP and local legislation prior to admission to the trial. If the child is unable to give assent at the time of the emergency, the assent, when applicable will be obtained as soon as feasible. Group B: - A condition requiring an emergency surgery or invasive procedure where adequate haemostasis is required. Emergency is defined as need for surgery or intervention within the following 8 hours. - Currently taking dabigatran etexilate in the context of a clinical trial with dabigatran etexilate (1160.106 or 1160.108). - Male or female patients from 0 to less than 18 years of age at the time of informed consent/assent for participation in trial 1160.106 or in trial 1160.108. - Female patients of childbearing potential (defined as having experienced menarche) must have followed the contraception requirements according to the dabigatran trial 1160.106 or trial 1160.108 in which they are enrolled. - Written informed consent provided by the patient (and/or the patient¿s legally accepted representative) and assent provided by the patient (if applicable) at the time of informed consent signature in accordance with GCP and local legislation prior to admission to the trial. If the child is unable to give assent at the time of the emergency, the assent, when applicable will be obtained as soon as feasible. Are the trial subjects under 18? yes Number of subjects for this age range: 9 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 1 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Group A: - Patients with minor bleeding (e.g. epistaxis, haematuria) who can be managed with standard supportive care. - Patients with no clinical signs of bleeding. - Patients with body weight < 2.5 kg - Contraindications to trial medication including known hypersensitivity to the drug or its excipients; i.e. patients with hereditary fructose intolerance who may react to sorbitol or infants with unknown hereditary fructose intolerance status. - Female patients who are pregnant, nursing, or who plan to become pregnant while in the trial. Group B: - A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low. - Patients with body weight < 2.5 kg - Contraindications to trial medication including known hypersensitivity to the drug or its excipients; i.e. patients with hereditary fructose intolerance who may react to sorbitol or infants with unknown hereditary fructose intolerance status. - Female patients who are pregnant, nursing, or who plan to become pregnant while in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To demonstrate the safety of idarucizumab, as assessed by the occurrence of patients with drug related adverse events (including immune reactions) and all-cause mortality in paediatric venous thromboembolism (VTE) patients treated with dabigatran in ongoing clinical trials who require emergency surgery/urgent procedures or patients who have life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid reversal of the anticoagulant effects of dabigatran is needed.;Secondary Objective: Assessments of the reversal of dabigatran, bleeding status or emergency surgery/urgent procedures, clinical outcomes, pharmacokinetics of dabigatran and idarucizumab.; Primary end point(s): 1: Safety of idarucizumab in a paediatric population as assessed by the occurrence of drug-related adverse events (including immune reactions) and all-cause mortality during the trial. ; Timepoint(s) of evaluation of this end point: 1: 30 days post-dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1: Percent change of coagulation tests (dTT, ECT) at 30 minutes post-dose compared to pre-dose. 2: Time to achieve complete reversal of dabigatran effect, based on coagulation tests (dTT and ECT). 3: Duration of complete reversal of dabigatran effect sustained at 24 hours post-dose, based on coagulation tests (dTT and ECT). 4: Cessation of bleeding (Group A patients only). 5: Bleeding status and other clinical conditions that may contribute to bleeding (Group A patients only) during the trial. 6: Development of treatment-emergent ADA with cross reactivity to idarucizumab at 30 days post-dose of idarucizumab (binary). ; Timepoint(s) of evaluation of this end point: 1: 30 minutes post-dose 2: Up to 24 hours post-dose 3: Up to 24 hours post-dose 4: Up to 24 hours post-dose 5: 30 days post-dose 6: 30 days post-dose | — |
Countries
Austria, Belgium, Bulgaria, Canada, Czech Republic, Finland, France, Germany, Greece, Italy, Lithuania, Norway, Russian Federation, Spain, Sweden, Switzerland, Turkey, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim
Outcome results
None listed