Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06590974
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
A Study of Freeze-dried Human Protein C Concentrate TAK-662 in Participants with Congenital Protein C Deficiency
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Special Drug Use Surveillance Study of Ceprotin for Intravenous Injection 1000IU All-Case Surveillance
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is conducted in Japan of Freeze-dried Human Protein C Concentrate TAK-662 used to treat participants with congenital protein C deficiency
The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency TAK-662
During the study participants with congenital protein C deficiency will be administered with TAK-662 intravenous injection in under routine normal practice The investigators will evaluate adverse events due to TAK-662 for 12 months For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation the investigator will evaluate for 24 months as a maximum The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study
The main aim of the study is to evaluate for adverse events and effectiveness of congenital protein C deficiency TAK-662
During the study participants with congenital protein C deficiency will be administered with TAK-662 intravenous injection in under routine normal practice The investigators will evaluate adverse events due to TAK-662 for 12 months For participants who will be administered in long-term supplementation of TAK-662 after acute treatment or short-term supplementation the investigator will evaluate for 24 months as a maximum The study sponsor will not be involved in how the participants are administered but will be recorded what happens during the study
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None