E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
E.1.1.1 | Medical condition in easily understood language |
serious bleeding/surgery or procedure after treatment with dabigatran |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 16.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019524 |
E.1.2 | Term | Hemorrhage |
E.1.2 | System Organ Class | 100000004866 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Evaluate the reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran |
|
E.2.2 | Secondary objectives of the trial |
Evaluate safety and the pharmacokinetcs of the idarucizumab-dabigatran complex. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Group A (Bleeding patients)
-- Overt bleeding judged by the physician to require a reversal agent
-- Currently taking dabigatran etexilate
-- At least 18 years of age
-- Written informed consent
- Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or procedure for a condition other than bleeding
-- Condition requiring emergency surgery or procedure where adequate hemostasis is required. Emergency is defined as within the next 4 hours.
-- Current treatment with dabigatran
-- At least 18 years of age
-- Writen Informed consent. |
|
E.4 | Principal exclusion criteria |
- Group A (Bleeding Patients)
-- Patients with minor bleeds (epistaxis, hematuria) who can be managed with standard supportive care.
-- Patients with no clinical signs of bleeding
-- Contraindications to study medication including known hypersensitivity to the drug or its excipients.
- Group B (Patients who require emergency surgery or procedure)
-- A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
-- Contraindications to study medication including known hypersensitiity to the drug or its excipients. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1: Reversal of anticoagulant effect of dabigatran
|
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1: Minimum unbound sum (free) dabigatran
2: Reversal of dTT or ECT after the first infusion and before the start of the second
3: Reversal of aPTT
4: Reversal of TT
5: Duration of reversal
6: Occurrence of major bleeding post-surgery (for Group B only)
7: Time to cessation of bleeding (for Group A only)
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|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: up to 4 hours
2: up to 15 minutes
3: up to 4 hours
4: up to 4 hours
5: up to 24 hours
6: up to 24 hours
7: up to 24 hours
|
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 183 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Belgium |
Canada |
China |
Denmark |
France |
Ireland |
Italy |
Japan |
Netherlands |
New Zealand |
Norway |
Portugal |
Slovakia |
Sweden |
Argentina |
Australia |
Brazil |
Chile |
Colombia |
Czech Republic |
Estonia |
Finland |
Germany |
Hong Kong |
India |
Korea, Republic of |
Latvia |
Lebanon |
Spain |
Israel |
Mexico |
Poland |
Russian Federation |
Singapore |
South Africa |
Taiwan |
United Kingdom |
United States |
|
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | 16 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 16 |