Date: 2016-08-15
Type of
information: Initiation of the trial
phase:
Announcement: initiation of the trial
Company: Boehringer Ingelheim (Germany)
Product: Praxbind® (idarucizumab)
Action
mechanism:
- monoclonal antibody. Idarucizumab is a fully humanized antibody fragment, or Fab, being investigated as a specific antidote for Pradaxa®. Pre-clinical studies indicate idarucizumab binds specifically to and inhibits dabigatran with no other expected interactions.
- Praxbind® is the first and only specific non-vitamin K antagonist oral anticoagulant (NOAC) reversal agent approved for use in emergency situations when immediate reversal of the anticoagulant effect of Pradaxa® is required.
Disease: specific antidote for Pradaxa® - reversion of the anticoagulant effect of dabigatran due to uncontrolled life-threatening bleeding requiring urgent intervention or a need to undergo an emergency surgery/urgent invasive procedure.
Therapeutic
area: Cardiovascular diseases - Cerebrovascular diseases
Country:
Trial
details:
- The global, multi-centre RE-VECTO Surveillance Program will collect data on Praxbind® (idarucizumab) usage patterns in a clinical practice setting. The program will enroll at least 300 patients, and all hospital pharmacies where Praxbind® is used are eligible to participate. Collected data will include information such as: The hospital pharmacy dispensing Praxbind®, Patient characteristics, Why Praxbind® was used – which hospital department administered it, under what circumstances, total dose administered, timings of administration, and if any adverse events occurred. Study completion is expected by the end of 2018.
Latest
news:
- • On August 15, 2016, Boehringer Ingelheim announced its global RE-VECTO program for Praxbind® (idarucizumab), the specific reversal agent for Pradaxa® (dabigatran etexilate mesylate).
- Praxbind® is indicated for patients treated with Pradaxa®, when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding. This indication is approved under accelerated approval based on a reduction in unbound dabigatran and normalization of coagulation parameters in healthy volunteers. Continued approval for this indication may be contingent upon the results of an ongoing cohort case series study. The emergency situations in which Praxbind® may be used can vary greatly, such as a car accident requiring emergency surgery or a severe bleeding event. Data captured in RE-VECTO will help to better understand the actual usage of Praxbind® in the clinical practice setting.
- Data for RE-VECTO will be captured through hospital pharmacies where Praxbind® is dispensed and will include information about the types of patients and situations in which Praxbind® was utilized. The data gathered from RE-VECTO will help shape future information and education on Praxbind® to healthcare providers and patients.
Accelerated approval for Praxbind® was granted based on results from Phase I data in healthy volunteers and the efficacy and safety of Praxbind® continues to be evaluated in RE-VERSE AD™ - a phase III global clinical trial. Results from an interim analysis of RE-VERSE AD show that Praxbind® immediately reversed the anticoagulant effect of dabigatran, the active ingredient in Pradaxa®, in critically ill and high-risk patients in emergency situations.
Is
general: Yes
