An observational study in Thrombotic Thrombocytopenic Purpura (TTP), sponsored by Takeda. Recruiting at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Takeda · Observational
This study is a survey in Japan of recombinant ADAMTS13 used to treat or to prevent participants with congenital thrombotic thrombocytopenic purpura (cTTP). The study sponsor will not be involved in how the participants are treated but will provide instructions on how the clinics will record what happens during the study.
The main aim of the study is to check for side effects related from recombinant ADAMTS13 and to check if recombinant ADAMTS13 improves or prevents cTTP.
During the study, participants with cTTP will take recombinant ADAMTS13 intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from recombinant ADAMTS13 for 18 months.
67 studies on the registry are indexed under Purpura, Thrombotic Thrombocytopenic; 18 are open to participants now.
This study's planned enrollment of 40 is below the median of 156 across 27 observational studies indexed under Purpura, Thrombotic Thrombocytopenic.
Browse Purpura, Thrombotic Thrombocytopenic studies →Takeda is the lead sponsor of 1,026 studies on the registry; 89 are open to participants now.
Of its 178 completed or terminated interventional studies of FDA-regulated products, 154 (87%) have results posted.
Counted across the registry records on this site, refreshed daily.
The population of this survey are all participants who meet the inclusion/exclusion criteria.
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- All participants with congenital thrombotic thrombocytopenic purpura (cTTP), treated with recombinant ADAMTS13
Exclusion Criteria:
- None
Participants will receive recombinant ADAMTS13 intravenous injection.
Drug: Recombinant ADAMTS13
Recombinant ADAMTS13, Intravenous injection
Also known as: ADZYNMA Intravenous 1500, TAK-755
Number of Participants who Experience at Least One Treatment-Emergent Adverse Events (TEAE)
Time frame: Up to 18 Months
Percent Change in Observed Platelet Count from Baseline at the End of Treatment
Percent change in platelet count from baseline at the end of treatment will be reported.
Time frame: Up to 18 Months
Percent Change in Observed ADAMTS13 Activity from Baseline at the End of Treatment
Percent change in ADAMTS13 activity from baseline at the end of treatment will be reported.
Time frame: Up to 18 Months
Percent Change in Observed ADAMTS13 Inhibitor from Baseline at the End of Treatment
Percent change in ADAMTS13 inhibitor from baseline at the end of treatment will be reported.
Time frame: Up to 18 Months
Number of Participants with Thrombotic Thrombocytopenic Purpura (TTP) Events on Periodic Replacement Therapy
Number of participants with TTP events on periodic replacement therapy will be reported.
Time frame: Up to 18 Months
Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Data sharing details ↗ · vivli.org
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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