Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorbers GLOBAFFIN® and LIGASORB® and IgE Immunoadsorber IgEnio® in Clinical Routine (SEPIAR)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Autoimmune Diseases
- Type
- Observational
- Design
- Observational Model: OtherTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorbers GLOBAFFIN®, LIGASORB® and IgEnio® in clinical routine according to their intended use over a time peroid of 5 years. The primary objective for the IgG adsorber GLOBAFFIN® and LIG...
The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorbers GLOBAFFIN®, LIGASORB® and IgEnio® in clinical routine according to their intended use over a time peroid of 5 years. The primary objective for the IgG adsorber GLOBAFFIN® and LIGASORB® is the estimation of the mean relative reduction in total IgG from pre- to post-treatment per treatment session. The primary objective for the IgE adsorber IgEnio® is the estimation of the mean relative reduction in total IgE from pre- to post-treatment per treatment session.
Tracking Information
- NCT #
- NCT04078698
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Jan T. Kielstein, Prof. Dr. Städtisches Klinikum Braunschweig
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