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)
Status: Recruiting
Location: See all (22) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Florida
University of Florida - Shands
RECRUITING
Gainesville
Massachusetts
Beth Israel Deaconess Medical Center
RECRUITING
Boston
Brigham and Women's Hospital
NOT_YET_RECRUITING
Boston
Massachusetts General Hospital
RECRUITING
Boston
Minnesota
University of Minnesota Clinical Research Unit
RECRUITING
Minneapolis
North Carolina
Duke University Medical Center
RECRUITING
Durham
Leo Jenkins Cancer Center/ECU School of Medicine
RECRUITING
Greenville
New Jersey
Rutgers University
RECRUITING
New Brunswick
New York
Weill Cornell
RECRUITING
New York
Ohio
Ohio State University
RECRUITING
Columbus
Utah
University of Utah Health Sciences Center
RECRUITING
Salt Lake City
Wisconsin
Versiti Wisconsin, Inc.
RECRUITING
Milwaukee
Other Locations
Austria
AKH - Medizinische Universitat Wien
NOT_YET_RECRUITING
Vienna
Greece
General Hospital of Thessaloniki G. Papanikolaou
NOT_YET_RECRUITING
Thessaloniki
Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico
NOT_YET_RECRUITING
Milan
Azienda Ospedaliero-Universitaria Citta della Salute e della Scienza di Torino
NOT_YET_RECRUITING
Torino
Spain
Hospital de Cruces
NOT_YET_RECRUITING
Barakaldo
Hospital General Universitario Gregorio Maranon
NOT_YET_RECRUITING
Madrid
Hospital Universitario Virgen del Rocio
NOT_YET_RECRUITING
Seville
Hospital Universitari i Politecnic La Fe
NOT_YET_RECRUITING
Valencia
United Kingdom
Royal Liverpool University Hospital
RECRUITING
Liverpool
University College London Hospital
RECRUITING
London
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date:2023-03-21
Estimated Completion Date:2026-06-11
Participants
Target number of participants:33
Treatments
Experimental: Part 1: TAK-755 Dose 1 in Acute Phase and Dose 2 in 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.
Experimental: Part 1: TAK-755 Dose 2 in Both Acute and 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.
Experimental: Part 2: TAK-755 Dose 3 in Acute Phase and Dose 2 in Post-acute Phase
TAK-755 Dose 3, IV infusion, in the acute phase until 48-hour platelet response is achieved. All participants achieving platelet response will receive TAK-755 at Dose 2, 4 times per week for Week 1 and 3 times per week for Week 2 and 3 during the post-acute phase based on investigator judgement as high-risk for developing iTTP recurrence.