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

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

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

Study Overview

• Status: Recruiting
• Conditions: Autoimmune Diseases
• Intervention / Treatment: Device: Immunoadsorber GLOBAFFIN®

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Celina Erfle; Phone Number: +49 6172 609 93208; Email: celina.erfle@fmc-ag.com
• Study Contact Backup: Name: Manuela Stauss-Grabo, Dr.; Phone Number: +49 6172 609 5248; Email: Manuela.Stauss-Grabo@fmc-ag.com

Study Locations

• Germany
  • Flensburg, Germany, 24939
    • Recruiting
    • Diakonissenkrankenhaus Flensburg
    • Contact: W Ries, MD
  • Ulm, Germany, 89081
    • Recruiting
    • University of Ulm - Department of Neurology
    • Contact: Dorst Johannes, Prof.Dr.
  • Niedersachsen
    • Braunschweig, Niedersachsen, Germany, 38126
      • Recruiting
      • Städtisches Klinikum Braunschweig
      • Contact: Jan T. Kielstein, Prof. Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment with the IgG immunoadsorber GLOBAFFIN®; Treatment with the IgG immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.	Device: Immunoadsorber GLOBAFFIN®; Documentation of the treatment with one of the immunoadsorber GLOBAFFIN® depending on the patient's underlying disease

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean relative reduction in disease-specific IgG, total IgM and total IgA	5 years
Clinical effect of the treatment measured by the physician's judgement as well as indication specific scores	5 years

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events and serious adverse events during the treatment, reported incidents, device deficiencies and handling problems	5 years
Reduction of laboratory safety parameters	5 years

Collaborators and Investigators

• Sponsor: Fresenius Medical Care Deutschland GmbH
• Collaborators: Alcedis GmbH
• Investigators: Principal Investigator: Jan T. Kielstein, Prof. Dr., Städtisches Klinikum Braunschweig

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2019
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: September 2, 2019
• First Submitted That Met QC Criteria: September 2, 2019
• First Posted (Actual): September 6, 2019

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 12, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Therapeutic apheresis; Immune apheresis
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases
• Other Study ID Numbers: TA-IA-03-INT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No