A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
Completed · Phase 2
Conditions studied: Thrombotic Thrombocytopenic Purpura (TTP)
In brief
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.
Key facts
- Study ID
- NCT05714969
- Run by
- Takeda
- People needed
- 29
- Starts
- 2023-07-21
- Expected to finish
- 2026-04-16
- Last updated by the study team
- 2026-06-17
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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
Full record on ClinicalTrials.gov
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