Ignite Creation Date:
2024-05-06 @ 5:04 PM
Last Modification Date:
2024-10-26 @ 2:21 PM
Study NCT ID:
NCT05181618
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-14
First Post:
2021-12-06
Brief Title:
A Study to Evaluate Overall Health Physical Activity and Joint Outcomes in Participants With Severe or Moderate Hemophilia A Without Factor VIII Inhibitors on Emicizumab Prophylaxis
Sponsor:
Hoffmann-La Roche
Organization:
Hoffmann-La Roche
Study Overview
Official Title:
A Multicenter Open-Label Phase IV Study to Evaluate Overall Health Physical Activity and Joint Outcomes in Participants Aged 13 and 70 Years With Severe or Moderate Hemophilia A Without FVIII Inhibitors on Emicizumab Prophylaxis
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
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:
Beyond ABR
Brief Summary:
Study MO42623 is a Phase IV multicenter open-label three cohort study designed to evaluate the impact of emicizumab prophylaxis on overall health physical activity and joint outcomes in participants aged 13 and 70 years with severe hemophilia A without factor VIII FVIII inhibitors or moderate hemophilia A without FVIII inhibitors who are receiving FVIII prophylaxis and who will start emicizumab treatment as part of this study
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 |
|---|---|---|---|
| ISRCTN10101701 | REGISTRY | ISRCTN | None |
| 2020-005092-13 | EUDRACT_NUMBER | None | None |
| 2023-505747-40-00 | REGISTRY | None | None |