Status:
COMPLETED
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine
Lead Sponsor:
Fresenius Medical Care Deutschland GmbH
Collaborating Sponsors:
Alcedis GmbH
Conditions:
Autoimmune Diseases
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 ob...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 15 2025
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04078698
Start Date
September 5 2019
End Date
August 15 2025
Last Update
September 4 2025
Active Locations (3)
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1
Städtisches Klinikum Braunschweig
Braunschweig, Lower Saxony, Germany, 38126
2
Diakonissenkrankenhaus Flensburg
Flensburg, Germany, 24939
3
University of Ulm - Department of Neurology
Ulm, Germany, 89081