SEPIAR: Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorbers GLOBAFFIN® and LIGASORB® in Clinical Routine
Study Details
Study Description
Brief Summary
Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorbers GLOBAFFIN® and LIGASORB® in clinical routine according to their intended use.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
The objective of the study is the documentation of the safety and effectiveness profile of the CE-labeled immunoadsorbers GLOBAFFIN® and LIGASORB® in clinical routine according to their intended use.
The primary objective for the IgG adsorber GLOBAFFIN® and LIGASORB® is the estimation of the mean relative reduction in total IgG from pre- to post-treatment per treatment session.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment with the IgG immunoadsorbers GLOBAFFIN® or LIGASORB® Treatment with the IgG immunoadsorbers GLOBAFFIN® or LIGASORB® in clinical routine according to their intended use. |
Device: Immunoadsorbers GLOBAFFIN® orLIGASORB®
Documentation of the treatment with one of the immunoadsorbers GLOBAFFIN® or LIGASORB® depending on the patient's underlying disease
|
Outcome Measures
Primary Outcome Measures
- Relative reduction in total IgG from pre- to post-treatment (for GLOBAFFIN and LIGASORB treatments) [5 years]
Secondary Outcome Measures
- 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 Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Minimum age of 18 years
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Informed consent signed and dated by study patient and investigator/authorised physician
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Ability to understand the nature and requirements of the study
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Treatment with one of the immunoadsorber systems GLOBAFFIN® orLIGASORB® according to the intended use.
Exclusion Criteria:
General:
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Any condition which could interfere with the patient's ability to comply with the study
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Pregnancy or lactation period
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Participation in an interventional clinical study during the preceding 30 days.
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Participation in an interventional clinical study with pharmacological active substances (e.g. therapeutic antibodies) during the preceding 60 days.
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Any deviation from the intended use
Study-specific:
Any contraindication listed in the valid instruction for use:
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Hypersensitivity or allergy against any materials used in either the immunoadsorber column or the extracorporeal circuit
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Inability to withstand the stress of an extracorporeal treatment procedure due to their age, their physical developments or their clinical constitution
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Previously demonstrated hypersensitivity associated with therapeutic apheresis
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No suitable anticoagulation treatment, such as due to known hypersensitivity to heparin or ACD-A
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Haemorrhagic diathesis in which extracorporeal apheresis procedures and anticoagulation performed have a high bleeding hazard
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Severe cardiovascular disease, so that extracorporeal treatment is not possible
-
Acute, systemic infection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Städtisches Klinikum Braunschweig | Braunschweig | Niedersachsen | Germany | 38126 |
| 2 | Diakonissenkrankenhaus Flensburg | Flensburg | Germany | 24939 |
Sponsors and Collaborators
- Fresenius Medical Care Deutschland GmbH
- Alcedis GmbH
Investigators
- Principal Investigator: Jan T. Kielstein, Prof. Dr., Städtisches Klinikum Braunschweig
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- TA-IA-03-INT