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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 29, 2014