Details of the SBP

General Information of Synthetic Binding Protein (SBP) (ID: SBP003380)
SBP Name
Fab Idarucizumab
Synonyms
BI-655075; Praxbind; Prizbind
Design Method Traditional methods (Site-directed mutagenesis and/or Directed evolution)
Highest Status Marketed
SBP Sequence
>VH Chain
QVQLQESGPGLVKPSETLSLTCTVSGFSLTSYIVDWIRQPPGKGLEWIGVIWAGGSTGYN
SALRSRVSITKDTSKNQFSLKLSSVTAADTAVYYCASAAYYSYYNYDGFAYWGQGTLVTV
SSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQ
SSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSC
>VL Chain
DVVMTQSPLSLPVTLGQPASISCKSSQSLLYTDGKTYLYWFLQRPGQSPRRLIYLVSKLD
SGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQSTHFPHTFGGGTKVEIKRTVAAPSV
FIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSL
SSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Protein Scaffold Information of This SBP
Scaffold ID PS034
Scaffold Info
[1]
Scaffold Name Fab
Scaffold Class Antibody fragment
Fold Type Beta-Sheets + Loops
Binding Target(s) of This SBP (BTS)
BTS Name Details Mechanism Application Affinity Research Organization Ref
Dabigatran
BTS Info
Binder Blood coagulation disorders N.A. Rush University Medical Center; Boehringer Ingelheim [1]
Clinical Trial Information of This SBP
NCT01688830 Click to show the Detail
Indication Healthy
Phase Phase I
Title Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 Administered Alone or With Dabigatran Etexilate
Status Completed
Sponsor Boehringer Ingelheim
NCT01722786 Click to show the Detail
Indication Severe Bleeding; Urgent Surgery
Phase .
Title Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists
Status Completed
Sponsor Cardioangiologisches Centrum Bethanien
NCT01955720 Click to show the Detail
Indication Hemorrhage
Phase Phase I
Title Safety, Tolerability, PK and PD of BI 655075 and Establishment of BI 655075 Dose(s) Effective to Reverse Prolongation of Blood Coagulation Time by Dabigatran
Status Completed
Sponsor Boehringer Ingelheim
NCT02028780 Click to show the Detail
Indication Healthy
Phase Phase I
Title Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BI 655075 (Idarucizumab) Administered Alone or With Dabigatran Etexilate in Japanese Healthy Subjects
Status Completed
Sponsor Boehringer Ingelheim
NCT02104947 Click to show the Detail
Indication Hemorrhage
Phase Phase III
Title Reversal of Dabigatran Anticoagulant Effect With Idarucizumab
Status Completed
Sponsor Boehringer Ingelheim
NCT02745054 Click to show the Detail
Indication Blood Coagulation
Phase .
Title Safety of Oral Anticoagulants Registry
Status Unknown
Sponsor Hospital Quality Foundation
NCT02798107 Click to show the Detail
Indication Hemorrhage
Phase .
Title Observational Study to Evaluate Safety of Idarucizumab in Pediatric Patients
Status Withdrawn
Sponsor Boehringer Ingelheim
NCT02815670 Click to show the Detail
Indication Hemorrhage
Phase Phase III
Title Reversal Dabigatran Anticoagulant Effect With Idarucizumab
Status Completed
Sponsor Boehringer Ingelheim
NCT02831660 Click to show the Detail
Indication Hemorrhage
Phase Phase III
Title CU Programme of Idarucizumab for Japanese Patients
Status Completed
Sponsor Boehringer Ingelheim
NCT03086356 Click to show the Detail
Indication Healthy Volunteers
Phase Phase I
Title Study to Investigate the Pharmacokinetics (PK) and Pharmacodynamics (PD) of Idarucizumab in Chinese Healthy Male and Female Volunteers Who Had Taken Dabigatran Etexilate and Whose Plasma Concentrations of Dabigatran Were at or Close to Steady State
Status Completed
Sponsor Boehringer Ingelheim
NCT03254147 Click to show the Detail
Indication Atrial Fibrillation
Phase .
Title Medical Need of OAC Reversal
Status Completed
Sponsor Boehringer Ingelheim
NCT03343704 Click to show the Detail
Indication Hemorrhage
Phase Phase III
Title This Study Looks at the Effects of Idarucizumab in Patients Who Take Dabigatran and Need Emergency Surgery or Are Bleeding
Status Completed
Sponsor Boehringer Ingelheim
NCT03359889 Click to show the Detail
Indication Thromboembolism
Phase .
Title PraxbindTM India PMS Program
Status Completed
Sponsor Boehringer Ingelheim
NCT03537521 Click to show the Detail
Indication Severe Bleeding; Urgent Surgery
Phase .
Title Reversal Agent Use in Patients Treated With Direct Oral Anticoagulants or Vitamin K Antagonists (RADOA). Focus on New Antidots
Status Withdrawn
Sponsor Cardioangiologisches Centrum Bethanien
NCT04062097 Click to show the Detail
Indication Intracranial Hemorrhage
Phase .
Title Registration of Idarucizumab for Patients With IntraCranial Hemorrhage
Status Recruiting
Sponsor University Hospital, Essen
NCT04195113 Click to show the Detail
Indication Atrial Fibrillation; Venous Thromboembolism; Arterial Vascular Disease
Phase .
Title Perioperative Anticoagulant Use for Surgery Evaluation Emergency Registry
Status Recruiting
Sponsor McMaster University
References
1 Idarucizumab for the Reversal of Dabigatran. Ann Emerg Med. 2017 May;69(5):554-558.