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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

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

Locations
Other Locations
Japan
Takeda selected site
RECRUITING
Tokyo
Contact Information
Primary
Takeda Contact
medinfoUS@takeda.com
+1-877-825-3327
Time Frame
Start Date: 2024-05-30
Estimated Completion Date: 2032-09-30
Participants
Target number of participants: 40
Treatments
Recombinant ADAMTS13
Participants will receive recombinant ADAMTS13 intravenous injection.
Related Therapeutic Areas
Sponsors
Leads: Takeda

This content was sourced from clinicaltrials.gov

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