NCT01410903

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 5, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

1.3 years

First QC Date

August 4, 2011

Last Update Submit

August 18, 2015

Conditions

Systemic Scleroderma

Outcome Measures

Primary Outcomes (1)

  • survival under immunoadsorption

    6 months

Secondary Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (1)

TheraSorb Ig

EXPERIMENTAL
Device: TheraSorb Ig

Interventions

TheraSorb IgDEVICE

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

Also known as: Ig-TheraSorb, code 330-000-452
TheraSorb Ig

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsklinikum Dresden

Dresden, 01307, Germany

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Study Officials

  • Martin Aringer, Prof.

    Universitätsklinikum Dresden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2011

First Posted

August 5, 2011

Study Start

April 1, 2011

Primary Completion

July 1, 2012

Study Completion

August 1, 2012

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

DE(1)