NCT04078698CompletedNot Applicable
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine (SEPIAR)
Fresenius Medical Care Deutschland GmbH6 sites in 1 country34 target enrollmentStarted: September 5, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 34
- Locations
- 6
- Primary Endpoint
- Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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
Outcomes
Primary Outcomes
Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®
Time Frame: 5 years
Secondary Outcomes
- 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)
Investigators
Study Sites (6)
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