Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06015750
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-11
First Post:
2023-08-23
Brief Title:
Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa STRENSIQ for Hypophosphatasia
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
An Interventional Prospective Open-Label Study of Immunosuppressive Therapies to Mitigate Immune-Mediated Loss of Therapeutic Response to Asfotase Alfa STRENSIQ for Hypophosphatasia RESTORE
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
RESTORE
Brief Summary:
The primary objective of this study is to evaluate the effect of immunosuppressive therapy IST in participants treated with asfotase alfa who demonstrate immune-mediated loss of effectiveness LoE
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 |
|---|---|---|---|
| AA-HPP-407 | OTHER | None | None |
| 2022-502793-17 | EUDRACT_NUMBER | Alexion | None |