Immunoadsorption in Patients With Severe Systemic Sclerosis

NCT ID: NCT01410903

Last Updated: 2015-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-08-31

Brief Summary

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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

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Conditions

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Systemic Scleroderma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TheraSorb Ig

Group Type EXPERIMENTAL

TheraSorb Ig

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Ig-TheraSorb code 330-000-452

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Miltenyi Biomedicine GmbH

INDUSTRY

Sponsor Role collaborator

GWT-TUD GmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Martin Aringer, Prof.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Dresden

Locations

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Universitätsklinikum Dresden

Dresden, , Germany

Site Status

Countries

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Germany

Other Identifiers

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IAS - SSc 2010

Identifier Type: -

Identifier Source: org_study_id

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