Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine

Launched by FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH · Sep 2, 2019

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a treatment called GLOBAFFIN®, which is used for patients with autoimmune diseases. Autoimmune diseases occur when the body's immune system mistakenly attacks its own cells, leading to various health problems. The trial aims to gather information on how well GLOBAFFIN® works in real-life clinical settings and ensure it is safe for patients.

To participate in this study, you need to be at least 18 years old and able to understand what the study involves. You will also need to provide your consent and have treatment with the GLOBAFFIN® system as intended. However, certain conditions may prevent you from joining, such as being pregnant, having severe health issues, or recent participation in other clinical studies. If you choose to participate, you can expect to receive the GLOBAFFIN® treatment while the researchers monitor your safety and response to the therapy throughout the study.

Gender

ALL

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