Clinical trial NCT04078698: Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine
Official title: Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine (SEPIAR)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autoimmune Diseases
Keywords: Therapeutic apheresis
Immune apheresis
Lead sponsor: Fresenius Medical Care Deutschland GmbH
Sponsor class: INDUSTRY
Collaborators: name: Alcedis GmbH
First posted: 2019-09-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multi-centre, open-label, non-comparative, interventional study
Primary purpose: TREATMENT

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 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 criteria: 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

Primary outcomes:
measure: Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®
timeFrame: 5 years
Secondary outcomes:
measure: Mean relative reduction in disease-specific IgG, total IgM and total IgA
timeFrame: 5 years
measure: Clinical effect of the treatment measured by the physician's judgement as well as indication specific scores
timeFrame: 5 years
Other outcomes:
measure: Adverse events and serious adverse events during the treatment, reported incidents, device deficiencies and handling problems
timeFrame: 5 years
measure: Reduction of laboratory safety parameters
timeFrame: 5 years
Locations:
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig
state: Niedersachsen
city: Flensburg
country: Germany
facility: Diakonissenkrankenhaus Flensburg
city: Ulm
country: Germany
facility: University of Ulm - Department of Neurology
Study officials:
affiliation: Academic Teaching Hospital Braunschweig
name: Jan T. Kielstein, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: