Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04876365
Status:
COMPLETED
Last Update Posted:
2023-07-24
First Post:
2021-05-05
Brief Title:
A Study in Children Teenagers and Adults With Severe Hemophilia A Who Switched From Other Factor VIII Treatments to Adynovate
Sponsor:
Takeda
Organization:
Takeda
Study Overview
Official Title:
Real-World Effectiveness of PEGylated Recombinant Antihemophilic Factor Adynovate Prophylaxis in Patients With Hemophilia A in Canada A Retrospective Intra-patient Comparison With a Before-After Design
Status:
COMPLETED
Status Verified Date:
2023-07
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:
The main aims of the study are to assess the safety profile of Adynovate as well as how well people respond to the preventive treatment with Adynovate
This study is about reviewing and collecting data of the participants before and after the switch to Adynovate that are already available No new information will be collected during this study The total time for data collection in the study will be approximately 72 months 36 months before and 36 months after switching to Adynovate Participants will not receive Adynovate as part of this study
As participants are not treated in this study they do not need to visit their doctor in addition to their normal visits
This study is about reviewing and collecting data of the participants before and after the switch to Adynovate that are already available No new information will be collected during this study The total time for data collection in the study will be approximately 72 months 36 months before and 36 months after switching to Adynovate Participants will not receive Adynovate as part of this study
As participants are not treated in this study they do not need to visit their doctor in addition to their normal visits
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| MACS-2020-061601 | OTHER | Takeda | None |