A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
Thrombotic Thrombocytopenic Purpura (TTP)
About this trial
This is an interventional treatment trial for Thrombotic Thrombocytopenic Purpura (TTP) focused on measuring Drug Therapy, Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
Eligibility Criteria
Key Inclusion Criteria 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 Participant has received more than 2 pre-study PEX prior to randomization. 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.
Sites / Locations
- University of Florida Shands
- Brigham and Women's Hospital
- University if Minnesota Med CARRecruiting
- Rutgers University
- Weill Cornell Medical College New York Presbyterian HospitalRecruiting
- Duke University Medical CenterRecruiting
- Leo Jenkins Cancer Center/ECU School of MedicineRecruiting
- Ohio State UniversityRecruiting
- University of Utah
- Versiti Clinical Trials and Research Office
- Clinica Zabala
- Hospital Universitario Austral
- AKH- Medizinische Universitat WienRecruiting
- General Hospital Of Athens LaikoRecruiting
- University Hospital of PatraRecruiting
- General Hospital of Thessaloniki "G. Papanikolaou"Recruiting
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
- Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
- Instytut Hematologii i Transfuzjologii
- Hospital de CrucesRecruiting
- Hospital General Universitario Gregorio Maranon
- Hospital Universitario Virgen del RocioRecruiting
- Hospital Universitari i Politecnic La FeRecruiting
- Hospital Universitario Dr. PesetRecruiting
- Royal Liverpool University Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
TAK-755 Dose 1 in Acute Phase and Dose 2 in Post-acute Phase
TAK-755 Dose 2 in Both Acute and Post-Acute Phase
TAK-755 Dose 1, IV infusion, in the acute phase until clinical response is achieved. All participants achieving clinical response will receive TAK-755 at Dose 2, for up to 6 weeks during the post-acute phase.
TAK-755 Dose 2, IV infusion, in the acute phase until clinical response is achieved. All participants achieving clinical response will receive TAK-755 at Dose 2, for up to 6 weeks during the post-acute phase.