Phase
Condition
N/ATreatment
TAK-755
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria (Part 1 and Part 2)
Participant must provide a signed informed consent form. A fully recognized proxy may be used per local laws for participants unable to provide consent.
Participant is 18 years or older at time of screening.
Participant has been diagnosed with de novo or relapsed iTTP.
Participant must be willing to fully comply with study procedures and requirements.
Female participants of childbearing potential must present with a negative pregnancy test and agree to employ highly effective birth control measures for duration of study. Sexually active male participants must agree to use an effective method of contraception for the duration of the study.
Key Exclusion Criteria (Part 1 and Part 2)
Participant has received more than 2 pre-study PEX prior to randomization in Part 1 or first dose of investigational product in Part 2.
Participant has been diagnosed with cTTP or another cause of thrombotic microangiopathy (TMA).
Participant has been exposed to another investigational product within 30 days prior to enrollment or is scheduled to participate in another clinical study involving investigational product or investigational device during the course of the study.
Participant has received caplacizumab within 30 days prior to study enrollment.
Participant has had a previous iTTP event within the past 30 days.
Participant is positive for human immunodeficiency virus (HIV) with unstable disease or cluster of differentiation (CD)4+ count ≤200 cells/mm^3 within 3 months of screening.
Participant has condition of severe immunodeficiency.
Participant has a severe systemic acute infection.
Participant has another underlying progressive fatal disease and/or life expectancy <3 months.
Participant is identified by the investigator as being unable or unwilling to cooperate with study procedures.
Participant is pregnant or lactating.
Participant has any condition in which methylprednisolone or other steroid equivalent is contraindicated as per prescribing information.
Participant has known life-threatening hypersensitivity reaction, including anaphylaxis, to the parent molecule ADAMTS13, Chinese hamster ovary (CHO) cell proteins, or other constituents of TAK-755.
Study Design
Study Description
Connect with a study center
Clinica Zabala
Buenos Aires,
ArgentinaSite Not Available
Hospital Universitario Austral
Buenos Aires,
ArgentinaSite Not Available
AKH- Medizinische Universitat Wien
Vienna,
AustriaSite Not Available
London Health Sciences Centre
London, Ontario
CanadaSite Not Available
St. Michael's Hospital
Toronto, Ontario
CanadaSite Not Available
University Health Network
Toronto, Ontario
CanadaSite Not Available
Universitaetsklinikum Essen
Essen, 45147
GermanySite Not Available
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt, 60590
GermanySite Not Available
Universitaetsklinikum Koeln
Koeln, 50937
GermanySite Not Available
General Hospital Of Athens Laiko
Athens,
GreeceSite Not Available
University Hospital of Patra
Patra,
GreeceSite Not Available
General Hospital of Thessaloniki "G. Papanikolaou"
Thessaloniki,
GreeceSite Not Available
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
Milan,
ItalySite Not Available
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
Torino,
ItalySite Not Available
Instytut Hematologii i Transfuzjologii
Warszawa,
PolandSite Not Available
Hospital de Cruces
Barakaldo,
SpainSite Not Available
Hospital General Universitario Gregorio Maranon
Madrid,
SpainSite Not Available
Hospital Universitario Virgen del Rocio
Sevilla,
SpainSite Not Available
Hospital Universitari i Politecnic La Fe
Valencia,
SpainSite Not Available
Hospital Universitario Dr. Peset
Valencia,
SpainSite Not Available
Royal Liverpool University Hospital
Liverpool,
United KingdomSite Not Available
University College London Hospital
London,
United KingdomSite Not Available
University of Florida Shands
Gainesville, Florida 32610
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesSite Not Available
Brigham and Women's Hospital
Boston, Massachusetts 02215
United StatesSite Not Available
Massachusetts General Hospital
Boston, Massachusetts 02114
United StatesSite Not Available
University if Minnesota Med CAR
Minneapolis, Minnesota 55455
United StatesSite Not Available
University of Minnesota
Minneapolis, Minnesota 55455
United StatesSite Not Available
Rutgers University
New Brunswick, New Jersey 08901
United StatesSite Not Available
Weill Cornell Medical College New York Presbyterian Hospital
New York, New York 10021
United StatesSite Not Available
Duke University Medical Center
Durham, North Carolina 27710
United StatesSite Not Available
Leo Jenkins Cancer Center/ECU School of Medicine
Greenville, North Carolina 27834
United StatesSite Not Available
Ohio State University
Columbus, Ohio 43210
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84106
United StatesSite Not Available
Versiti Clinical Trials and Research Office
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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