Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2025-12-26 @ 1:28 AM
Study NCT ID:
NCT06461533
Status:
RECRUITING
Last Update Posted:
2025-06-04
First Post:
2024-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Survey of Susoctocog Alfa (Genetical Recombination) in Participants With Acquired Haemophilia A
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
General Use-results Survey of OBIZER for I.V. Injection (All-case Surveillance)
Status:
RECRUITING
Status Verified Date:
2025-05
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 Susoctocog Alfa (Genetical Recombination) intravenous injection used to treat participants with bleeding events of acquired Haemophilia A (AHA). 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 Susoctocog Alfa (Genetical Recombination) intravenous injection and to check if Susoctocog Alfa (Genetical Recombination) intravenous injection improves bleeding events of AHA.
During the study, participants with AHA will take Susoctocog Alfa (Genetical Recombination) intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from Susoctocog Alfa (Genetical Recombination) intravenous injection for up to 90 days after the last dose of study drug or until discontinued (varied from participant to participant).
The main aim of the study is to check for side effects related from Susoctocog Alfa (Genetical Recombination) intravenous injection and to check if Susoctocog Alfa (Genetical Recombination) intravenous injection improves bleeding events of AHA.
During the study, participants with AHA will take Susoctocog Alfa (Genetical Recombination) intravenous injection according to their clinic's standard practice. The study doctors will check for side effects from Susoctocog Alfa (Genetical Recombination) intravenous injection for up to 90 days after the last dose of study drug or until discontinued (varied from participant to participant).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: