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A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
Sponsor: Takeda
Summary
This is a study of TAK-755 in adults with immune-mediated thrombotic thrombocytopenic purpura (iTTP). The main aim of this study is to determine the percentage of participants with a clinical (Part 1) or platelet (Part 2) response without plasma exchange during the study. Participants who have an acute attack of iTTP will receive TAK-755 and immunosuppressive therapy during their stay at the hospital until they achieve a clinical response in Part 1 or platelet response in Part 2. Participants will also be treated with TAK-755 for an additional time of up to 6 weeks after the acute phase. In total, participants will stay in the study for approximately 3 months.
Official title: A Phase 2b, Multicenter, Randomized, Double-blind Study of Safety and Efficacy of TAK-755 (rADAMTS13) With Minimal to No Plasma Exchange (PEX) in the Treatment of Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
33
Start Date
2023-03-21
Completion Date
2026-06-11
Last Updated
2026-03-09
Healthy Volunteers
No
Interventions
TAK-755
TAK-755 IV infusion
Locations (22)
University of Florida - Shands
Gainesville, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Minnesota Clinical Research Unit
Minneapolis, Minnesota, United States
Rutgers University
New Brunswick, New Jersey, United States
Weill Cornell
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Leo Jenkins Cancer Center/ECU School of Medicine
Greenville, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
University of Utah Health Sciences Center
Salt Lake City, Utah, United States
Versiti Wisconsin, Inc.
Milwaukee, Wisconsin, United States
AKH - Medizinische Universitat Wien
Vienna, Austria
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki, Greece
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan, Italy
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino, Italy
Hospital Universitario Virgen del Rocio
Seville, Sevilla, Spain
Hospital de Cruces
Barakaldo, Vizcaya, Spain
Hospital General Universitario Gregorio Maranon
Madrid, Spain
Hospital Universitari i Politecnic La Fe
Valencia, Spain
University College London Hospital
London, Greater London, United Kingdom
Royal Liverpool University Hospital
Liverpool, Merseyside, United Kingdom