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NCT02815670 | SNCTP000002125

Sicherheitsstudie zu Idarucizumab bei Kindern und Jugendlichen, die Dabigatranetexilat bekommen.

Data source: BASEC (Imported from 24.05.2020), WHO (Imported from 22.03.2020)
Changed: 22.05.2020
Disease category: Arterielle und venöse Erkrankungen, inkl. tiefe Venenthrombose und Lungenembolie

Brief description of trial (Source of data: BASEC)

Dies ist eine Medikamenten-Studie mit Idarucizumab zur Behandlung und Sekundärprävention von venösen Thromboembolien bei Kindern und jungen
Erwachsenen. Idarucizumab wird an Kindern geprüft, die bereits Dabigatranetexilat bekommen und bei denen entweder eine schwere Blutung aufgetreten ist, die durch dieses Prüfpräparat gestoppt werden kann, oder die sich einer Notoperation oder einer dringenden medizinischen Intervention mit Blutungsrisiko unterziehen müssen, bei der dieses Prüfpräparat
einige der Blutungen verhindern kann.
Geplante letzte Patientenvisite: 28.02.2020 (global)

Health conditions investigated (Source of data: BASEC)

venöse Thromboembolie

Health conditions (Source of data: WHO)

Hemorrhage

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Die Studie ist in 3 Teile unterteilt:
- Voruntersuchung: Einige Untersuchungen und Massnahmen werden bei der ersten Visite durchgeführt, um festzustellen, ob die Voraussetzungen für eine Teilnahme an der Studie erfüllt sind.
- Behandlung: Das Prüfpräparat wird in zwei getrennten intravenösen
Injektionen/Infusionen über einen Zeitraum von etwa 30 Minuten gegeben.
- Sicherheitsnachbeobachtung: 24 Stunden nach der Verabreichung von Idarucizumab erfolgt eine Untersuchung. Ausserdem finden 7 Tage und 30 Tage nach Verabreichung des Prüfpräparats zwei weitere Visiten zur Nachbeobachtung statt.

Interventions (Source of data: WHO)

Drug: Idarucizumab

Criteria for participation in trial (Source of data: BASEC)

Gruppe A:
Patienten, die Dabigatranetexilat einnehmen und bei denen eine lebensbedrohliche oder unkontrollierbare Blutung auftritt, die ein dringendes medizinisches oder chirurgisches Eingreifen erforderlich macht.

Gruppe B:
Patienten, die Dabigatran einnehmen und bei denen keine Blutung aufgetreten ist, aber bei denen aufgrund eines Ereignisses (mit Ausnahme des Auftretens von Blutungen) eine Notoperation/ein dringender Eingriff erforderlich ist, bei dem die antikoagulatorische Wirkung von Dabigatran unerwünscht ist.

Exclusion criteria (Source of data: BASEC)

Gruppe A:
Patienten, bei denen eine geringfügige Blutung auftritt, die durch Standardbehandlung kontrolliert werden kann.
Patienten mit weniger als 2.5 kg Gewicht.

Gruppe B:
Patienten, bei denen eine Operation geplant ist, die ein geringes Risiko schwerwiegender Blutungen hat.
Patienten mit weniger als 2.5 kg Gewicht.

Inclusion/Exclusion Criteria (Source of data: WHO)


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 Good Clinical Practice (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.

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.

- 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.

- Female patients who are pregnant, nursing, or who plan to become pregnant while in the
trial.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02815670

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02815670

Further information on trial

Date trial registered

24.06.2016

Incorporation of the first participant

07.09.2016

Recruitment status

Completed

Academic title (Source of data: WHO)

Single Dose, Open Label, Uncontrolled, Safety Trial of Intravenous Administration of Idarucizumab to Paediatric Patients Enrolled From Ongoing Phase IIb/III Clinical Trials With Dabigatran Etexilate for the Treatment and Secondary Prevention of Venous Thromboembolism.

Type of trial (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Source of data: WHO)

Phase 3

Primary end point (Source of data: WHO)

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.

Secundary end point (Source of data: WHO)

Cessation of bleeding (Group A patients only).;Bleeding status and other clinical conditions that may contribute to bleeding (Group A patients only) during the trial.;Percent change of coagulation tests (diluted thrombin time, ecarin clotting time) at 30 minutes post-dose compared to pre-dose.;Time to achieve complete reversal of dabigatran effect, based on coagulation tests (diluted thrombin time, ecarin clotting time).;Duration of complete reversal of dabigatran effect sustained at 24 hours post-dose, based on coagulation tests (diluted thrombin time, ecarin clotting time).;Development of treatment-emergent anti drug antibodies with cross reactivity to idarucizumab at 30 days post-dose of idarucizumab.

Contact information (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Lausanne, Zürich

Countries (Source of data: WHO)

Argentina, Austria, Belgium, Brazil, Canada, Czech Republic, Czechia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Mexico, Norway, Russian Federation, Sweden, Switzerland, Taiwan, Turkey, Ukraine, United Kingdom, United States

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

PD Dr. Manuela Albisetti Pedroni
+41 44 266 7138
manuela.albisetti@kispi.uzh.ch

Contact for general information (Source of data: WHO)

Boehringer Ingelheim
Boehringer Ingelheim

Contact for scientific information (Source of data: WHO)

Boehringer Ingelheim
Boehringer Ingelheim

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Boehringer Ingelheim

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2017-00003

Secondary ID (Source of data: WHO)

2015-002177-37;1321.7