RecruitingNCT06441578

A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura

Special Drug Use Surveillance of ADZYNMA Intravenous 1500 (All-Case Investigation)


Sponsor

Takeda

Enrollment

40 participants

Start Date

May 30, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Inclusion Criteria1

  • \- All participants with congenital thrombotic thrombocytopenic purpura (cTTP), treated with recombinant ADAMTS13

Exclusion Criteria1

  • \- None

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Interventions

DRUGRecombinant ADAMTS13

Recombinant ADAMTS13, Intravenous injection


Locations(1)

Takeda selected site

Tokyo, Japan

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NCT06441578


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