Immunoadsorption in Patients With Severe Systemic Sclerosis

GWT-TUD

Status: Terminated

Conditions: Systemic Scleroderma

Treatments: Device: TheraSorb Ig

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01410903

IAS - SSc 2010

Details and patient eligibility

About

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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

TheraSorb Ig

Experimental group

Treatment:

Device: TheraSorb Ig