Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-31 @ 4:16 PM
Study NCT ID:
NCT06955793
Status:
AVAILABLE
Last Update Posted:
2025-05-02
First Post:
2025-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Expanded Access to TAK-881 for Children and Teenagers With Primary Immunodeficiency Diseases in the USA
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Expanded Access Program for United States of America: TAK-881 Subcutaneous for the Treatment of Primary Immunodeficiency Diseases (PIDD)
Status:
AVAILABLE
Status Verified Date:
2025-04
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 expanded access program allows people to gain access to an unlicensed treatment on compassionate grounds. This study will provide access to TAK-881 for participants with PIDD who have completed study TAK-881-3002 \[NCT06076642\], who continue to derive clinical benefit from maintenance treatment with TAK-881 and wish to continue this treatment.
All participants will receive TAK-881 as subcutaneous (SC) injection using a qualified medical device (Koru 24 G HIgH Flo Subcutaneous Safety Needle Set) that will be individualized for each participant, at the treating physician's discretion and dependent on serum IgG trough level and clinical response.
Participants will continue treatment until the benefit-risk no longer favors the participant or TAK-881 becomes commercially available in the United States (U.S.), the participant chooses to discontinue treatment, or the program is discontinued by the sponsor.
All participants will receive TAK-881 as subcutaneous (SC) injection using a qualified medical device (Koru 24 G HIgH Flo Subcutaneous Safety Needle Set) that will be individualized for each participant, at the treating physician's discretion and dependent on serum IgG trough level and clinical response.
Participants will continue treatment until the benefit-risk no longer favors the participant or TAK-881 becomes commercially available in the United States (U.S.), the participant chooses to discontinue treatment, or the program is discontinued by the sponsor.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| TAK-881-3002 PIDD EAP | OTHER | Takeda | View |