Abelacimab
BiologicalAbelacimab provided as liquid in vial (150 mg/mL)
Other names: MAA868
NCT Number: NCT07739888
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)
Trial opening soon.
Get Notified65 year and older
All sexes
Interventional
Phase 3
Patients who provide consent, will need to complete the end of treatment visit (EoT) assessments of the Core Part of CMAA868A2302 (ANT-010/NCT05712200) prior to receiving first dose in the OLE. Day 1 visit or dosing should occur on same day as EoT visit to avoid treatment interruption.
Participation in OLE will end if a patient permanently discontinues study treatment, or the study is completed or terminated by the Sponsor.
All patients will need to complete End of Study in Extension visit in person followed by a phone call visit 30 days after End of Extension visit. Any updates in AE or concomitant medications will be reported by a phone call/video call visit.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other protocol defined Inclusion/Exclusion criteria may apply
Abelacimab provided as liquid in vial (150 mg/mL)
Other names: MAA868
Time frame: Up to 3 years
Time to first International Society on Thrombosis and Haemostasis (ISTH) major bleeding events
Time frame: Up to 3 years
Time to first Bleeding Academic Research Consortium (BARC) type 3c/5 bleeding
Time frame: Up to 3 years
Number of participants with International Society on Thrombosis and Haemostasis (ISTH) major or clinically relevant non-major (CRNM) bleeding
Time frame: Up to 3 years
All suspected bleeding events either reported by the patient or observed by the Investigator
Time frame: Up to 3 years
Number of participants with treatment emergent AEs (TEAEs) and treatment emergent SAEs (TESAEs)
Time frame: Up to 3 years
Number of participants with treatment discontinuations due to treatment emergent AEs (TEAEs)
Time frame: Up to 3 years
Time frame: Up to 3 years
Time to first event of ischemic stroke or systemic embolism (SE). Undetermined strokes will be counted as ischemic strokes
Contact information is provided by the study sponsor or research team.
Novartis Pharmaceuticals
Industry
A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)
Acronym: LILAC-TIMI 76
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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