Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2026-01-03 @ 5:34 AM
Study NCT ID:
NCT02303093
Status:
COMPLETED
Last Update Posted:
2021-06-29
First Post:
2014-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-Interventional Study on the Tolerability and Efficacy of IVIG
Sponsor:
Octapharma
Organization:
Study Overview
Official Title:
Non-Interventional Study on the Tolerability and Efficacy of IVIG
Status:
COMPLETED
Status Verified Date:
2021-06
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:
GAM 10-06
Brief Summary:
Non-Interventional Study on the Tolerability and Efficacy of octagam® 10%
Detailed Description:
A Non-Interventional Study on the Tolerability and Efficacy of Octagam 5% or 10% or panzyga. Patients with any indication (replacement and immonomodulation) as prescribed by the treating physician. Marketed Octagam 5% or 10% or panzyga will be used according to the investigator prescription; intravenous (iv) administration.The primary objective is to detect and evaluate adverse drug reactions (ADRs) occurring during or after the administration of Octagam or panzyga in any indication, age group or treatment regimen, where a causal relationship to the administration of Octagam or panzyga is suspected.
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?: