Immunoadsorption in Patients With Severe Systemic Sclerosis

Not Applicable

Terminated

• Conditions: Systemic Scleroderma
• Interventions: Device: TheraSorb Ig

• Registration Number: NCT01410903
• Lead Sponsor: GWT-TUD GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-08-04
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Primary Completion: 2012-07
• Study Completion: 2012-08
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-18
• Last Update Posted: 2015-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TheraSorb Ig	TheraSorb Ig	-

Primary Outcome Measures

Name	Time	Method
survival under immunoadsorption	6 months

Secondary Outcome Measures

Name	Time	Method
survival under immunoadsorption	12 months
Number of Serious Adverse Events	12 months
change in "modified Rodnan Skin Score"	12 months
change in Diffusing Capacity of the Lung for Carbon Monoxide	12 months
change in Scleroderma Health Assenssment Questionnaire	12 months
change of pulmonary arterial pressure	12 months
reoccurrence of finger ulcers	12 months
healing of finger ulcers	12 months

Trial Locations

Locations (1)

Universitätsklinikum Dresden; 🇩🇪 Dresden, Germany