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Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension

Primary Purpose

Idiopathic Pulmonary Arterial Hypertension

Status

Completed

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

TheraSorb® - Ig flex

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Arterial Hypertension focused on measuring Pulmonary Hypertension, Pulmonary Arterial Hypertension, TheraSorb, immunoadsorption

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Able to understand and willing to sign the Informed Consent Form
age > 18 and < 80 years at time of informed consent
Idiopathic pulmonary arterial hypertension diagnosed by right heart catheter
WHO functional classification III
Application of conventional IPAH therapy, which has been stable for the prior 8 weeks
Able to perform a 6-minute-walk test (MWT)
Negative pregnancy test (β-HCG) at the start of the trial and appropriate contraception throughout the trial for women with child-bearing potential.

Exclusion Criteria:

Pregnancy and/or lactation
PAH of any cause other than permitted in the inclusion criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease
Contraindication for right heart catheterization
Any change in disease-targeted therapy within 8 weeks prior to inclusion
Walking impairment due to causes other than IPAH that would preclude performance of a 6MWT
Any patient who has received any investigational medication within 8 weeks prior to the start of this trial or who is scheduled to receive another investigational drug during the course of the trial between visits V1 and V9
Known intolerance to immunoadsorption in general or to one of the excipients (e.g. sheep antibodies or agarose) or other supporting agents
Hemoglobin concentration of < 75% below the lower limit of normal
Systolic blood pressure < 85 mmHg
Lack of compliance or other similar reason that, in the judgment of the Investigator, precludes satisfactory participation in the trial
Concurrent severe or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled generalized viral, bacterial and/ or mycotic infection) which by assessment of the treating Investigator could compromise patients safety or participation in the study
Drug or alcohol abuse within the last 5 years
Hypercoagulability
Known severe immunodeficiency (e.g. AIDS)
Severe lung disease: FEV1/FVC < 50%, total capacity < 60% of normal value
Indications that prohibit transient anticoagulation using Heparin and/or ACD-A-solutions

Sites / Locations

Thoraxklinik am Universitätsklinikum Heidelberg in cooperation with Nierenzentrum Heidelberg
Universitätsmedizin Greifswald, Zentrum für Innere Medizin, Klinik und Poliklinik für Innere Medizin B
Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin und Zentrum für Molekulare Medizin
Deutsches Herzzentrum Berlin, Klinik für Herz-, Thorax- und Gefäßchirurgie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Immunoadsorption

Arm Description

Patients are treated with the TheraSorb® Ig flex adsorber used exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy (5 treatments) performed over 5 to 8 consecutive days

Outcomes

Primary Outcome Measures

Primary endpoint is the change of pulmonary vascular resistance (PVR) at rest before immunoadsorption compared to 3 months after immunoadsorption therapy determined by right heart catheterization (RHC).

Secondary Outcome Measures

all-cause mortality

The patients will be followed for the duration of the study participation, an expected average of 6 months.

occurrence and number of Adverse Events

The patients will be followed for the duration of the study participation, an expected average of 6 months.

Six-minute walk test (6MWT)

Quality of life questionnaires

SF-36 EQ-5D™

WHO functional classification

WHO functional classification of pulmonary hypertension (according to the Evian Symposium,1998, modified New York Heart Association (NYHA) Classification

Analysis of Hemodynamics by right heart catheterization: RAP, PAPm, CO, CI, SvO2; sPAP

(Right atrial pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, cardiac output, cardiac index, venous oxygen saturation, systolic pulmonary arterial pressure.)

Reduction of IgG

Full Information

NCT ID

NCT01613287

First Posted

May 29, 2012

Last Updated

July 8, 2020

Sponsor

Miltenyi Biotec B.V. & Co. KG

1. Study Identification

Unique Protocol Identification Number

NCT01613287

Brief Title

Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension

Official Title

A Clinical Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

June 2012 (undefined)

Primary Completion Date

August 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Miltenyi Biotec B.V. & Co. KG

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This clinical investigation is a medical device trial to examine the safety and efficacy of TheraSorb® Ig flex adsorber treatment (as an add-on to conventional treatment) used exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy (5 treatments) performed over 5 to 8 consecutive days in patients with Idiopathic Pulmonary Arterial Hypertension and WHO functional classification III.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Idiopathic Pulmonary Arterial Hypertension

Keywords

Pulmonary Hypertension, Pulmonary Arterial Hypertension, TheraSorb, immunoadsorption

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Immunoadsorption

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

TheraSorb® - Ig flex

Other Intervention Name(s)

Immunoadsorption

Intervention Description

TheraSorb® Treatment with one TheraSorb® Ig flex adsorber pair, used exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy. 5 treatments performed over 5 to 8 consecutive days.

Primary Outcome Measure Information:

Title

Time Frame

Baseline, 3 months after therapy

Secondary Outcome Measure Information:

Title

all-cause mortality

Description

The patients will be followed for the duration of the study participation, an expected average of 6 months.

Time Frame

~6months

Title

occurrence and number of Adverse Events

Description

The patients will be followed for the duration of the study participation, an expected average of 6 months.

Time Frame

~6 months

Title

Six-minute walk test (6MWT)

Time Frame

Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy

Title

Quality of life questionnaires

Description

SF-36 EQ-5D™

Time Frame

Measurements at baseline, and after ~1 month, ~3 months, ~6 months

Title

WHO functional classification

Description

WHO functional classification of pulmonary hypertension (according to the Evian Symposium,1998, modified New York Heart Association (NYHA) Classification

Time Frame

Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy

Title

Analysis of Hemodynamics by right heart catheterization: RAP, PAPm, CO, CI, SvO2; sPAP

Description

(Right atrial pressure, mean pulmonary arterial pressure, pulmonary capillary wedge pressure, cardiac output, cardiac index, venous oxygen saturation, systolic pulmonary arterial pressure.)

Time Frame

Measurements at baseline, after ~3 months

Title

Reduction of IgG

Time Frame

Measurements at baseline, during each treatment visit, ~1 week, ~1 month and ~3 months after start of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Able to understand and willing to sign the Informed Consent Form age > 18 and < 80 years at time of informed consent Idiopathic pulmonary arterial hypertension diagnosed by right heart catheter WHO functional classification III Application of conventional IPAH therapy, which has been stable for the prior 8 weeks Able to perform a 6-minute-walk test (MWT) Negative pregnancy test (β-HCG) at the start of the trial and appropriate contraception throughout the trial for women with child-bearing potential. Exclusion Criteria: Pregnancy and/or lactation PAH of any cause other than permitted in the inclusion criteria, e.g. concomitantly to portal hypertension, complex congenital heart disease, reversed shunt, HIV infection, suspected pulmonary veno-occlusive disease Contraindication for right heart catheterization Any change in disease-targeted therapy within 8 weeks prior to inclusion Walking impairment due to causes other than IPAH that would preclude performance of a 6MWT Any patient who has received any investigational medication within 8 weeks prior to the start of this trial or who is scheduled to receive another investigational drug during the course of the trial between visits V1 and V9 Known intolerance to immunoadsorption in general or to one of the excipients (e.g. sheep antibodies or agarose) or other supporting agents Hemoglobin concentration of < 75% below the lower limit of normal Systolic blood pressure < 85 mmHg Lack of compliance or other similar reason that, in the judgment of the Investigator, precludes satisfactory participation in the trial Concurrent severe or uncontrolled medical disease (i.e. uncontrolled diabetes, congestive heart failure, myocardial infarction within 6 months prior to the study, unstable and uncontrolled hypertension, chronic renal disease, or active uncontrolled generalized viral, bacterial and/ or mycotic infection) which by assessment of the treating Investigator could compromise patients safety or participation in the study Drug or alcohol abuse within the last 5 years Hypercoagulability Known severe immunodeficiency (e.g. AIDS) Severe lung disease: FEV1/FVC < 50%, total capacity < 60% of normal value Indications that prohibit transient anticoagulation using Heparin and/or ACD-A-solutions

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ekkehard Grünig, Prof. Dr.

Organizational Affiliation

Heidelberg University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Thoraxklinik am Universitätsklinikum Heidelberg in cooperation with Nierenzentrum Heidelberg

City

Heidelberg

State/Province

Baden-Wuerttemberg

ZIP/Postal Code

69126/ 69120

Country

Germany

Facility Name

Universitätsmedizin Greifswald, Zentrum für Innere Medizin, Klinik und Poliklinik für Innere Medizin B

City

Greifswald

State/Province

Mecklenburg-Western Pomerania

ZIP/Postal Code

17475

Country

Germany

Facility Name

Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin und Zentrum für Molekulare Medizin

City

Cologne

State/Province

North-Rhine Westphalia

ZIP/Postal Code

50937

Country

Germany

Facility Name

Deutsches Herzzentrum Berlin, Klinik für Herz-, Thorax- und Gefäßchirurgie

City

Berlin

ZIP/Postal Code

13353

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension

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