A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With I… (NCT05714969) | Clinical Trial Compass
CompletedPhase 2
A Study of TAK-755 (rADAMTS13) With Little to No Plasma Exchange (PEX) Treatment in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (iTTP)
United States29 participantsStarted 2023-03-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.
Exclusion criteria
✕. 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.
What they're measuring
1
Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs), and Adverse Event of Special Interest (AESIs) After Receiving any Dose of Investigational Product (IP)
Timeframe: Through study completion, approximately 12 weeks
✕. 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.