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

Autoimmune Diseases Clinical Trial

— SEPIAR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04078698
• Other study ID #: TA-IA-03-INT
• Status: Recruiting
• Phase: N/A
• Start date: September 5, 2019
• Est. completion date: April 2026

Study information

• Verified date: October 2023
• Source: Fresenius Medical Care Deutschland GmbH
• Contact: Manuela Stauss-Grabo, Dr.
• Phone: +49 6172 609 5248
• Email: Manuela.Stauss-Grabo[@]fmc-ag.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2026
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Minimum age of 18 years
• Informed consent signed and dated by study patient and investigator/authorised physician
• Ability to understand the nature and requirements of the study
• Treatment with one of the immunoadsorber system GLOBAFFIN® according to the intended use. Exclusion Criteria:

General:

• Any condition which could interfere with the patient's ability to comply with the study
• In case of female patients: pregnancy or lactation period (if patient is = 55 years old or have been surgically sterilized, a negative pregnancy test is not required)
• Participation in an interventional clinical study during the preceding 30 days.
• Participation in an interventional clinical study with pharmacological active substances (e.g. therapeutic antibodies) during the preceding 60 days.
• Any deviation from the intended use Study-specific:

Any contraindication listed in the valid instruction for use:

• Hypersensitivity or allergy against any materials used in either the immunoadsorber column or the extracorporeal circuit
• Inability to withstand the stress of an extracorporeal treatment procedure due to their age, their physical developments or their clinical constitution
• Previously demonstrated hypersensitivity associated with therapeutic apheresis
• No suitable anticoagulation treatment, such as due to known hypersensitivity to heparin or ACD-A
• Haemorrhagic diathesis in which extracorporeal apheresis procedures and anticoagulation performed have a high bleeding hazard
• Severe cardiovascular disease, so that extracorporeal treatment is not possible
• Acute, systemic infection

Related Conditions & MeSH terms

• Autoimmune Diseases

Intervention

Device:
• Immunoadsorber GLOBAFFIN®
Documentation of the treatment with one of the immunoadsorber GLOBAFFIN® depending on the patient's underlying disease

Locations

Country	Name	City	State
Germany	Städtisches Klinikum Braunschweig	Braunschweig	Niedersachsen
Germany	Diakonissenkrankenhaus Flensburg	Flensburg
Germany	University of Ulm - Department of Neurology	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
Fresenius Medical Care Deutschland GmbH	Alcedis GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events and serious adverse events during the treatment, reported incidents, device deficiencies and handling problems		5 years
Other	Reduction of laboratory safety parameters		5 years
Primary	Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®		5 years
Secondary	Mean relative reduction in disease-specific IgG, total IgM and total IgA		5 years
Secondary	Clinical effect of the treatment measured by the physician's judgement as well as indication specific scores		5 years