NCT02303093

Non-Interventional Study on the Tolerability and Efficacy of IVIG

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 344 (actual)
• Sponsor: Octapharma · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Primary and Secondary Immunodeficiency and Other Conditions Requiring Regular Administration of Octagam 5% or 10% IVIG

Interventions

Type	Name	Description
BIOLOGICAL	Octagam IVIG 5% or 10%	Octagam IVIG 5% or 10%
BIOLOGICAL	Panzyga	Panzyga

Timeline

• Start date: 2011-08-01
• Primary completion: 2020-06-05
• Completion: 2020-06-05
• First posted: 2014-11-27
• Last updated: 2021-06-29
• Results posted: 2021-06-29

Locations

38 sites across 5 countries: Austria, Canada, France, Spain, United Kingdom

Regulatory

• FDA-regulated drug study