Autoimmune Diseases
Conditions
Keywords
Therapeutic apheresis, Immune apheresis
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.
Interventions
DEVICEImmunoadsorber GLOBAFFIN®
Documentation of the treatment with one of the immunoadsorber GLOBAFFIN® depending on the patient's underlying disease
Sponsors
Alcedis GmbH
Fresenius Medical Care Deutschland GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, multi-centre, open-label, non-comparative, interventional study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN® | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Germany
Outcome results
None listed