LIBREXIA - AF A Phase 3, Randomized, Double-Blind, Double-Dummy, Parallel Group, Active Controlled Study to Evaluate the Efficacy and Safety of Milvexian, an Oral Factor XIa Inhibitor, Versus Apixaban in Participants with Atrial Fibrillation

Date Added
August 15th, 2023
PRO Number
Pro00130569
Researcher
James Phillips

List of Studies

Keywords
Cardiovascular, Drug Studies, Heart, Vascular
Summary

This is a study comparing the new class anticoagulants factor XIa to the FDA approved Apixaban. The study is to determine if Milvexian is as effective and safe with preventing clots for patients with A-fib and to determine if Milvexian is better at reducing the chances of bleeding.

Institution
MUSC Heart and Vascular Institute
Recruitment Contact
Jacqueline Sheriod-Scott
1-803-255-2927
sheriods@musc.edu

A seamless, phase 1b/2 multiple ascending dose/proof of concept study of XTMAB-16 in patients with pulmonary sarcoidosis with or without extrapulmonary manifestations

Date Added
November 21st, 2023
PRO Number
Pro00132408
Researcher
Walter James

List of Studies


Keywords
Lung
Summary

This is a seamless, Phase 1b/2 Multiple Ascending Dose (MAD)/Proof of Concept (POC) Study (hereafter referred to as Phase 2 Program) of XTMAB-16 in participants with pulmonary sarcoidosis with or without extrapulmonary involvement. The study is comprised of two parts: Part A is a randomized double-blind placebo-controlled multiple dose-escalating study, and Part B is a randomized double-blind placebo-controlled POC study.
The objective of Part A is to evaluate the safety and tolerability of MADs of XTMAB-16, and to determine the recommended Phase 2 dose and frequency for Part B for XTMAB-16 administration in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations.
The objective of Part B is to confirm preliminary efficacy of XTMAB-16 as measured by the ability to reduce background oral corticosteroid use in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations.

Institution
MUSC
Recruitment Contact
Robyn Empey
83-792-0965
recruitment@musc.edu



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