NCT06441578

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 40 (estimated)
• Sponsor: Takeda · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Thrombotic Thrombocytopenic Purpura (TTP)

Interventions

Type	Name	Description
DRUG	Recombinant ADAMTS13	Recombinant ADAMTS13, Intravenous injection

Timeline

• Start date: 2024-05-30
• Primary completion: 2032-09-30
• Completion: 2032-09-30
• First posted: 2024-06-04
• Last updated: 2025-10-07

Locations

1 site across 1 country: Japan