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

NCT04078698 | Completed

• 1 other identifier: TA-IA-03-INT
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Autoimmune Diseases

Keywords

Therapeutic apheresis; Immune apheresis

Outcome Measures

Primary Outcomes (1)

• Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®

  5 years

Secondary Outcomes (2)

• 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 Outcomes (2)

• 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

Study Arms (1)

Treatment with the IgG immunoadsorber GLOBAFFIN®

EXPERIMENTAL

Treatment with the IgG immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.

Device: Immunoadsorber GLOBAFFIN®

Interventions

Immunoadsorber GLOBAFFIN® DEVICE

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

Treatment with the IgG immunoadsorber GLOBAFFIN®

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Deutschland GmbH: lead
• Alcedis GmbH: collaborator

Study Sites (3)

Städtisches Klinikum Braunschweig

Braunschweig, Lower Saxony, 38126, Germany

Location

Diakonissenkrankenhaus Flensburg

Flensburg, 24939, Germany

Location

University of Ulm - Department of Neurology

Ulm, 89081, Germany

Location

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Jan T. Kielstein, Prof. Dr.

  Academic Teaching Hospital Braunschweig

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multi-centre, open-label, non-comparative, interventional study

Study Record Dates

• First Submitted: September 2, 2019
• First Posted: September 6, 2019
• Study Start: September 5, 2019
• Primary Completion: May 30, 2025
• Study Completion: August 15, 2025
• Last Updated: September 4, 2025

Record last verified: 2025-08

Locations

DE (3)