Ignite Creation Date:
2025-12-25 @ 2:05 AM
Ignite Modification Date:
2026-03-05 @ 2:32 PM
Study NCT ID:
NCT02293460
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2014-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety Study of I10E in Treatment of Patients With CIDP
Sponsor:
Laboratoire français de Fractionnement et de Biotechnologies
Organization:
Study Overview
Official Title:
An International, Multicentre, Efficacy and Safety Study of I10E in Initial and Maintenance Treatment of Patients With Chronic Inflammatory Demyelinating Polyradiculoneuropathy.
Status:
COMPLETED
Status Verified Date:
2021-01
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:
PRISM
Brief Summary:
Primary objective:
To assess the efficacy of I10E in improving the disability of patients with CIDP.
Secondary objective:
To assess the safety of I10E in patients with CIDP.
To assess the efficacy of I10E in improving the disability of patients with CIDP.
Secondary objective:
To assess the safety of I10E in patients with CIDP.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: