About this trial
This OLE part is an optional, single arm, multicenter, open-label extension (OLE) added to the core part to assess the long-term safety, tolerability, the incidence of ischemic stroke or SE and bleeding events of abelacimab in eligible patients who completed the double-blinded core part of CMAA868A2302 (ANT-010/NCT05712200)
Eligibility criteria
Qualifiers
Patients are able to provide written informed consent to enter the extension part.
Patients must be on study treatment at the time of EoT visit in the core part.
Disqualifiers
Patients meeting any exclusion criteria in the core part.
Patients who have a history or evidence of any clinically significant disorder, condition, or disease that in the investigator's opinion or Sponsor physician (if consulted), would put the participant at risk or interfere with the study participation
History of hypersensitivity to the study drug or its excipients, to drugs of similar chemical classes
Any medical or psychiatric condition which in the judgment of the Investigator either requires urgent medical intervention/hospitalization or may preclude patients from complying with study requirements for the duration of the study.
Trial design
Treatments tested in this trial
- Abelacimab