Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT05714969
PHASE2

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

View on ClinicalTrials.gov

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

BIOLOGICAL

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