- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01410903
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
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
-
-
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Dresden, Germany, 01307
- Universitätsklinikum Dresden
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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
|
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:
|
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
Collaborators
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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