Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2026-01-28 @ 5:50 PM
Study NCT ID:
NCT03684018
Status:
RECRUITING
Last Update Posted:
2025-10-20
First Post:
2018-09-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Two Dose Levels of Privigen in Pediatric CIDP
Sponsor:
CSL Behring
Organization:
Study Overview
Official Title:
Randomized Study of Two Dose Levels of Privigen in Pediatric CIDP
Status:
RECRUITING
Status Verified Date:
2025-10
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:
A randomized, open-label, prospective, multicenter study designed to investigate 2 dose levels in pediatric subjects 2 to ≤ 17 years of age with confirmed or possible CIDP, either previously exposed to IVIG treatment or unexposed to IVIG treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2018-003430-33 | EUDRACT_NUMBER | None | View |