Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Cli… (NCT04078698) | Clinical Trial Compass
CompletedNot Applicable
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine
Germany34 participantsStarted 2019-09-05
Plain-language summary
Documentation of the safety and effectiveness profile of the CE-labelled immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®