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

Primary Purpose

Autoimmune Diseases

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Immunoadsorber GLOBAFFIN®
Sponsored by
Fresenius Medical Care Deutschland GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autoimmune Diseases focused on measuring Therapeutic apheresis, Immune apheresis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 systems GLOBAFFIN® orLIGASORB® according to the intended use.

Exclusion Criteria:

General:

  • Any condition which could interfere with the patient's ability to comply with the study
  • Pregnancy or lactation period
  • 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

Sites / Locations

  • Städtisches Klinikum BraunschweigRecruiting
  • Diakonissenkrankenhaus FlensburgRecruiting
  • University of Ulm - Department of NeurologyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with the IgG immunoadsorber GLOBAFFIN®

Arm Description

Treatment with the IgG immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.

Outcomes

Primary Outcome Measures

Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®

Secondary Outcome Measures

Mean relative reduction in disease-specific IgG, total IgM and total IgA
Clinical effect of the treatment measured by the physician's judgement as well as indication specific scores

Full Information

First Posted
September 2, 2019
Last Updated
October 12, 2023
Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
Alcedis GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04078698
Brief Title
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine
Acronym
SEPIAR
Official Title
Documentation of the Safety and Effectiveness Profile of the IgG Immunoadsorber GLOBAFFIN® in Clinical Routine (SEPIAR)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 5, 2019 (Actual)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
April 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fresenius Medical Care Deutschland GmbH
Collaborators
Alcedis GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Diseases
Keywords
Therapeutic apheresis, Immune apheresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multi-centre, open-label, non-comparative, interventional study
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with the IgG immunoadsorber GLOBAFFIN®
Arm Type
Experimental
Arm Description
Treatment with the IgG immunoadsorber GLOBAFFIN® in clinical routine according to their intended use.
Intervention Type
Device
Intervention Name(s)
Immunoadsorber GLOBAFFIN®
Intervention Description
Documentation of the treatment with one of the immunoadsorber GLOBAFFIN® depending on the patient's underlying disease
Primary Outcome Measure Information:
Title
Relative reduction in total IgG from pre- to post-treatment for GLOBAFFIN®
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Mean relative reduction in disease-specific IgG, total IgM and total IgA
Time Frame
5 years
Title
Clinical effect of the treatment measured by the physician's judgement as well as indication specific scores
Time Frame
5 years
Other Pre-specified Outcome Measures:
Title
Adverse events and serious adverse events during the treatment, reported incidents, device deficiencies and handling problems
Time Frame
5 years
Title
Reduction of laboratory safety parameters
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manuela Stauss-Grabo, Dr.
Phone
+49 6172 609 5248
Email
Manuela.Stauss-Grabo@fmc-ag.com
First Name & Middle Initial & Last Name or Official Title & Degree
Celina Erfle
Phone
+49 6172 609 93208
Email
celina.erfle@fmc-ag.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan T. Kielstein, Prof. Dr.
Organizational Affiliation
Städtisches Klinikum Braunschweig
Official's Role
Principal Investigator
Facility Information:
Facility Name
Städtisches Klinikum Braunschweig
City
Braunschweig
State/Province
Niedersachsen
ZIP/Postal Code
38126
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan T. Kielstein, Prof. Dr.
Facility Name
Diakonissenkrankenhaus Flensburg
City
Flensburg
ZIP/Postal Code
24939
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
W Ries, MD
Facility Name
University of Ulm - Department of Neurology
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorst Johannes, Prof.Dr.

12. IPD Sharing Statement

Learn more about this trial

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

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