Hemorrhage

The trial objective is to demonstrate the safety of idarucizumab, as assessed by the occurrence of patients with drug related adverse events (including immune reactions) and allcause mortality in paediatric 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.

達栓普注射液/輸注液

Idarucizumab

solution for injection/ infusion

50ml/ vial

Primary endpoint:
The primary endpoint is the 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.

Group A:
1. Overt bleeding judged by the treating physician to require a reversal agent.
2. Currently taking dabigatran etexilate in the context of a clinical trial with dabigatran
etexilate (1160.106 or 1160.108).
3. 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.
4. 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.
5. 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:
1. 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.
2. Currently taking dabigatran etexilate in the context of a clinical trial with dabigatran
etexilate (1160.106 or 1160.108).
3. 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.
4. 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.
5. 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 A:
1. Patients with minor bleeding (e.g. epistaxis, haematuria) who can be managed with
standard supportive care.
2. Patients with no clinical signs of bleeding.
3. Patients with body weight < 2.5 kg
4. Contraindications to trial medication including known hypersensitivity to the drug or
its excipients; e.g. patients with known hereditary fructose intolerance who may
react to sorbitol.
5. Female patients who are pregnant, nursing, or who plan to become pregnant while in
the trial.
Group B:
1. A surgery or procedure which is elective or where the risk of uncontrolled or
unmanageable bleeding is low.
2. Patients with body weight < 2.5 kg
3. Contraindications to trial medication including known hypersensitivity to the drug or
its excipients; e.g. patients with known hereditary fructose intolerance who may
react to sorbitol.
4. Female patients who are pregnant, nursing, or who plan to become pregnant while in
the trial.