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Immunoadsorption in Patients With Severe Systemic Sclerosis

This study has been terminated.
(inadequately recruitment rate, funding is not secured)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01410903
First Posted: August 5, 2011
Last Update Posted: August 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Miltenyi Biotec GmbH
Information provided by (Responsible Party):
GWT-TUD GmbH
  Purpose
The purpose of this study is to evaluate source data for the survival and the investigation of the preliminary efficacy of immunoadsorption in patients with severe systemic sclerosis.

Condition Intervention
Systemic Scleroderma Device: TheraSorb Ig

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis

Resource links provided by NLM:


Further study details as provided by GWT-TUD GmbH:

Primary Outcome Measures:
  • survival under immunoadsorption [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • survival under immunoadsorption [ Time Frame: 12 months ]
  • Number of Serious Adverse Events [ Time Frame: 12 months ]
  • change in "modified Rodnan Skin Score" [ Time Frame: 12 months ]
  • change in Diffusing Capacity of the Lung for Carbon Monoxide [ Time Frame: 12 months ]
  • change in Scleroderma Health Assenssment Questionnaire [ Time Frame: 12 months ]
  • change of pulmonary arterial pressure [ Time Frame: 12 months ]
  • reoccurrence of finger ulcers [ Time Frame: 12 months ]
  • healing of finger ulcers [ Time Frame: 12 months ]

Enrollment: 1
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TheraSorb Ig Device: TheraSorb Ig
1,5 plasma volume per treatment venovenous immunoadsorption frequency: three times weekly in week 1 and 2, two times weekly in week 3-6, two times two-weekly in week 7-12 duration: 12 months
Other Names:
  • Ig-TheraSorb
  • code 330-000-452

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • systemic sclerosis according to the ACE-criteria
  • severe pulmonary manifestation with reduced DLCO
  • signed informed consent

Exclusion Criteria:

  • inadequate peripheral venous access
  • participation in another clinical trial
  • heart failure
  • pronounced allergic diathesis, particularly in case of known hypersensitivity to drugs and/or materials used in the extracorporeal circuit
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01410903


Locations
Germany
Universitätsklinikum Dresden
Dresden, Germany, 01307
Sponsors and Collaborators
GWT-TUD GmbH
Miltenyi Biotec GmbH
Investigators
Principal Investigator: Martin Aringer, Prof. Universitätsklinikum Dresden
  More Information

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01410903     History of Changes
Other Study ID Numbers: IAS - SSc 2010
First Submitted: August 4, 2011
First Posted: August 5, 2011
Last Update Posted: August 19, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
Sclerosis
Scleroderma, Systemic
Scleroderma, Diffuse
Pathologic Processes
Connective Tissue Diseases
Skin Diseases