Actively Recruiting
Special Drug Use Surveillance of ADZYNMA Intravenous 1500 (All-Case Investigation)
Led by Takeda · Updated on 2025-10-07
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying recombinant ADAMTS13, a treatment given by intravenous injection, for people with congenital thrombotic thrombocytopenic purpura (cTTP) in Japan. The main goal is to monitor side effects and see if this treatment helps prevent or improve cTTP. The study is observational, meaning the sponsor will not control how participants are treated but will guide how clinics record information. Participants will receive recombinant ADAMTS13 according to their clinic's usual care. The study will follow these participants for up to 18 months to observe their treatment experience. During this time, the treatment is given intravenously as part of standard medical practice. Throughout the study, doctors will check for any treatment-related side effects and measure changes in platelet count, ADAMTS13 activity, and ADAMTS13 inhibitor levels. The study will also track the number of TTP events during periodic replacement therapy. Participants' health and treatment outcomes will be monitored carefully during the 18-month period.
CONDITIONS
Brief Title
A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
Who Can Participate
Eligibility Criteria
You may qualify if you...
- All participants with congenital thrombotic thrombocytopenic purpura (cTTP), treated with recombinant ADAMTS13
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 18 months
Participants receive recombinant ADAMTS13 through intravenous injection.
Trial Site Locations
Total: 1 location
1
Takeda selected site
Tokyo, Japan
Actively Recruiting
Research Team
T
Takeda Contact
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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