Reversal of dabigatran anticoagulant effect with idarucizumab

• Register: EUCTR
• Last refreshed on: 9 January 2017
• Main ID: EUCTR2013-004813-41-EE
• Date of registration: 06/03/2014
• Prospective Registration: Yes
• Primary sponsor: Boehringer Ingelheim RCV GmbH & Co KG
• Public title: Reversal of dabigatran anticoagulant effect with idarucizumab
• Scientific title: A Phase III case series clinical study of the reversal of the anticoagulant effects of dabigatran by intravenous administration of 5.0g idarucizumab (BI 655075) in patients treated wtih dabigatran etexilate who have uncontrolled bleeding or require emergency surgery or procedures. RE-VERSE-AD (A study of the RE-VERSal Effects of Idarucizumab on Active Dabigatran) trial
• Date of first enrolment: 01/04/2014
• Target sample size: 250
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-004813-41
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Republic of, Latvia, Lebanon, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Russian Federation, Singapore, Slovakia, South Africa, Spain, Sweden, Taiwan, United Kingdom, United States

Contacts

• Name: QRPE PSC CT information Disclosure
• Affiliation: Boehringer Ingelheim GmbH & Co. KG

• Name: QRPE PSC CT information Disclosure
• Affiliation: Boehringer Ingelheim GmbH & Co. KG

Key inclusion & exclusion criteria

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 invasive procedure for a condition other than bleeding
-- Condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.
-- Current treatment with dabigatran
-- At least 18 years of age
-- Writen Informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

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. (subjects with hereditary fructose intolerance may react to sorbitol).
- Group B (Patients who are taking dabigatran who may not be bleeding, but do require an emergency surgery or invasive procedure for a condition other than bleeding)
-- 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. (subjects with hereditary fructose intolerance may react to sorbitol).


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Hemorrhage
MedDRA version: 17.0 Level: LLT Classification code 10019524 Term: Hemorrhage System Organ Class: 100000004866

Intervention(s)

Product Name: idarucizumab
Product Code: BI 655075
Pharmaceutical Form: Solution for injection/infusion
INN or Proposed INN: idarucizumab
Current Sponsor code: BI 655075
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

Secondary Objective: The secondary objectives are the assesment of bleeding, clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab

Timepoint(s) of evaluation of this end point: 1: up to 4 hours

Main Objective: Evaluate the reversal of the anticoagulant effect of dabigatran in patients after administration of idarucizumab

Primary end point(s): 1: Reversal of anticoagulant effect of dabigatran

Secondary Outcome(s)

Secondary end point(s): 1: Time to cessation of bleeding (for Group A only)

2: Occurence of major bleeding (for Group B only) intraoperatively and up to 24 hours post-surgery

3: Minimum unbound sum (free) dabigatran

4: Duration of reversal

5: Reversal of dTT or ECT after the first infusion and before the start of the second

6: Reversal of aPTT

7: Reversal of TT

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

Secondary ID(s)

1321.3

2013-004813-41-DE

Source(s) of Monetary Support

Boehringer Ingelheim RCV GmbH & Co KG