NCT04078698

Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine

Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine (SEPIAR)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Fresenius Medical Care Deutschland GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.

Detailed description

The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use. The primary objective for the IgG adsorber GLOBAFFIN® is the estimation of the mean relative reduction in total IgG from pre- to post-treatment per treatment session.

Conditions

• Autoimmune Diseases

Interventions

Type	Name	Description
DEVICE	Immunoadsorber GLOBAFFIN®	Documentation of the treatment with one of the immunoadsorber GLOBAFFIN® depending on the patient's underlying disease

Timeline

• Start date: 2019-09-05
• Primary completion: 2025-05-30
• Completion: 2025-08-15
• First posted: 2019-09-06
• Last updated: 2025-09-04

Locations

3 sites across 1 country: Germany