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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Miltenyi Biotec GmbH
ClinicalTrials.gov Identifier:
NCT01613287
First received: May 29, 2012
Last updated: December 6, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Idiopathic Pulmonary Arterial Hypertension
Device: TheraSorb® - Ig flex

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Miltenyi Biotec GmbH:

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). [ Time Frame: Baseline, 3 months after therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • all-cause mortality [ Time Frame: ~6months ] [ Designated as safety issue: Yes ]
    The patients will be followed for the duration of the study participation, an expected average of 6 months.

  • occurrence and number of Adverse Events [ Time Frame: ~6 months ] [ Designated as safety issue: Yes ]
    The patients will be followed for the duration of the study participation, an expected average of 6 months.

  • Six-minute walk test (6MWT) [ Time Frame: Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy ] [ Designated as safety issue: Yes ]
  • Quality of life questionnaires [ Time Frame: Measurements at baseline, and after ~1 month, ~3 months, ~6 months ] [ Designated as safety issue: No ]
    SF-36 EQ-5D™

  • WHO functional classification [ Time Frame: Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Measurements at baseline, after ~3 months ] [ Designated as safety issue: No ]
    (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 [ Time Frame: Measurements at baseline, during each treatment visit, ~1 week, ~1 month and ~3 months after start of treatment ] [ Designated as safety issue: No ]

Enrollment: 12
Study Start Date: June 2012
Study Completion Date: November 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Immunoadsorption
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
Device: TheraSorb® - Ig flex

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.

Other Name: Immunoadsorption

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01613287

Locations
Germany
Thoraxklinik am Universitätsklinikum Heidelberg in cooperation with Nierenzentrum Heidelberg
Heidelberg, Baden-Wuerttemberg, Germany, 69126/ 69120
Universitätsmedizin Greifswald, Zentrum für Innere Medizin, Klinik und Poliklinik für Innere Medizin B
Greifswald, Mecklenburg-Western Pomerania, Germany, 17475
Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin und Zentrum für Molekulare Medizin
Cologne, North-Rhine Westphalia, Germany, 50937
Deutsches Herzzentrum Berlin, Klinik für Herz-, Thorax- und Gefäßchirurgie
Berlin, Germany, 13353
Sponsors and Collaborators
Miltenyi Biotec GmbH
Investigators
Principal Investigator: Ekkehard Grünig, Prof. Dr. University of Heidelberg, Germany
  More Information

No publications provided

Responsible Party: Miltenyi Biotec GmbH
ClinicalTrials.gov Identifier: NCT01613287     History of Changes
Other Study ID Numbers: M-2010-224, CIV-11-10-002861
Study First Received: May 29, 2012
Last Updated: December 6, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Miltenyi Biotec GmbH:
Pulmonary Hypertension
Pulmonary Arterial Hypertension
TheraSorb
immunoadsorption

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014