This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding

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Boehringer Ingelheim

Status and phase

Completed
Phase 3

Conditions

Hemorrhage

Treatments

Drug: Idarucizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03343704
1321-0019

Details and patient eligibility

About

The primary objective is to demonstrate reversal of the anticoagulant effect of dabigatran in patients treated with dabigatran etexilate who have uncontrolled or life-threatening bleeding requiring urgent intervention, and in patients treated with dabigatran etexilate who require emergency surgery or other invasive procedure. The secondary objectives are to assess the reduction or cessation of bleeding, evaluate the clinical outcomes, safety and the pharmacokinetics of dabigatran in the presence of idarucizumab.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • ≥ 18 years at screening.
  • Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  • Currently taking dabigatran etexilate

They meet the following criteria:

  • Group A: Overt bleeding judged by the physician to require a reversal agent. OR
  • Group B: A condition requiring emergency surgery or invasive procedure where adequate hemostasis is required. Emergency is defined as within the following 8 hours.

Exclusion criteria

Group A:

  • Patients with minor bleeding (e.g. 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:

  • A surgery or procedure which is elective or where the risk of uncontrolled or unmanageable bleeding is low.
  • Contraindications to study medication including known hypersensitivity to the drug or its excipients (subjects with hereditary fructose intolerance may react to sorbitol).

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

19 participants in 2 patient groups

Group A - patients with uncontrolled or life-threatening bleeding
Experimental group
Treatment:
Drug: Idarucizumab
Group B - patients not bleeding but requiring emergency surgery or invasive procedure
Experimental group
Treatment:
Drug: Idarucizumab

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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