Immunoadsorption in Patients With Severe Systemic Sclerosis | NCT01410903

Studies
Immunoadsorption in Patients With Severe Systemic Sclerosis

NCT01410903

Sponsor

GWT-TUD GmbH

Status

Terminated

Last Update Posted

Aug 19, 2015Estimated

Enrollment

1Actual

Phase

Not Applicable

Conditions

Systemic Scleroderma

Interventions

TheraSorb Ig

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inadequately recruitment rate, funding is not secured

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Jul 2012Actual

Completion Date

Aug 2012Actual

First Submitted Date

Aug 4, 2011

First Submission Date that Met QC Criteria

Aug 4, 2011

First Posted Date

Aug 5, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 18, 2015

Last Update Posted Date

Aug 19, 2015Estimated

Name	Class
Miltenyi Biomedicine GmbH	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TheraSorb Ig	Experimental		Device: TheraSorb Ig

Interventions

Name	Type	Description	Arm Group Labels	Other Names
TheraSorb Ig	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
survival under immunoadsorption		6 months

Secondary Outcomes

Measure	Description	Time Frame
survival under immunoadsorption		12 months
Number of Serious Adverse Events		12 months
change in "modified Rodnan Skin Score"

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Martin Aringer, Prof.	Universitätsklinikum Dresden	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsklinikum Dresden		Dresden		01307	Germany

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided