Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441578
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2024-05-29
Brief Title:
A Survey of Recombinant ADAMTS13 in Participants With Congenital Thrombotic Thrombocytopenic Purpura
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Special Drug Use Surveillance of ADZYNMA Intravenous 1500 All-Case Investigation
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 clinics standard practice The study doctors will check for side effects from recombinant ADAMTS13 for 18 months
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 clinics standard practice The study doctors will check for side effects from recombinant ADAMTS13 for 18 months
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| jRCT2031240130 | REGISTRY | None | None |