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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04078698
Other study ID # TA-IA-03-INT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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