Immunoadsorption in Patients With Severe Systemic Sclerosis

August 18, 2015 updated by: GWT-TUD GmbH

Immunoadsorption in Addition to the Established Therapy in Patients With Systemic Sclerosis

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Dresden, Germany, 01307
        • Universitätsklinikum Dresden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
survival under immunoadsorption
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GWT-TUD GmbH

Collaborators

Miltenyi Biomedicine GmbH

Investigators

  • Principal Investigator: Martin Aringer, Prof., Universitätsklinikum Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

August 4, 2011

First Submitted That Met QC Criteria

August 4, 2011

First Posted (Estimate)

August 5, 2011

Study Record Updates

Last Update Posted (Estimate)

August 19, 2015

Last Update Submitted That Met QC Criteria

August 18, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IAS - SSc 2010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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