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Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine | Clinical Trials | Clareo Health

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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)

NCT04078698•Fresenius Medical Care Deutschland GmbH

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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
+5 more criteria

Locations (3)

Städtisches Klinikum Braunschweig

Braunschweig, Lower Saxony, Germany

Diakonissenkrankenhaus Flensburg

Flensburg, Germany

University of Ulm - Department of Neurology

Ulm, Germany

Key Dates

Start Date

September 5, 2019

Primary Completion Date

May 30, 2025

Completion Date

August 15, 2025

Last Updated

September 4, 2025

Enrollment

ACTUAL participants

Conditions

Autoimmune Diseases

Interventions

Immunoadsorber GLOBAFFIN®

DEVICE

Deciphering the Genetic Architecture of Autoimmune Diseases

NCT06948110

Autoimmune Diseases

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RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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Healthy ParticipantsHealthy Subjects+5 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Deciphering the Genetic Architecture of Autoimmune Diseases

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single- and Multiple-Ascending Doses and Food Effect of BGB-45035 in Healthy Participants and in Adults With Autoimmune Dermatological Diseases

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