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Immunoadsorption in Patients With Severe Systemic Sclerosis

This study has been terminated.
(inadequately recruitment rate, funding is not secured)
Sponsor:
Collaborator:
Miltenyi Biotec GmbH
Information provided by (Responsible Party):
GWT-TUD GmbH
ClinicalTrials.gov Identifier:
NCT01410903
First received: August 4, 2011
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis

Resource links provided by NLM:

MedlinePlus related topics: Scleroderma
U.S. FDA Resources

Further study details as provided by GWT-TUD GmbH:

Primary Outcome Measures:
  • survival under immunoadsorption [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • survival under immunoadsorption [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • Number of Serious Adverse Events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • change in "modified Rodnan Skin Score" [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • change in Diffusing Capacity of the Lung for Carbon Monoxide [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • change in Scleroderma Health Assenssment Questionnaire [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • change of pulmonary arterial pressure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • reoccurrence of finger ulcers [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • healing of finger ulcers [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: April 2011
Estimated 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: GWT-TUD GmbH
ClinicalTrials.gov Identifier: NCT01410903     History of Changes
Other Study ID Numbers: IAS - SSc 2010
Study First Received: August 4, 2011
Last Updated: July 9, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

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

ClinicalTrials.gov processed this record on June 18, 2013