Clinical trial NCT01613287: 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
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Pulmonary Arterial Hypertension
Keywords: Pulmonary Hypertension
Pulmonary Arterial Hypertension
TheraSorb
immunoadsorption
Lead sponsor: Miltenyi Biomedicine GmbH
Sponsor class: INDUSTRY
First posted: 2012-06-07
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: 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).
timeFrame: Baseline, 3 months after therapy
Secondary outcomes:
measure: all-cause mortality
timeFrame: ~6months
measure: occurrence and number of Adverse Events
timeFrame: ~6 months
measure: Six-minute walk test (6MWT)
timeFrame: Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy
measure: Quality of life questionnaires
timeFrame: Measurements at baseline, and after ~1 month, ~3 months, ~6 months
measure: WHO functional classification
timeFrame: Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy
measure: Analysis of Hemodynamics by right heart catheterization: RAP, PAPm, CO, CI, SvO2; sPAP
timeFrame: Measurements at baseline, after ~3 months
measure: Reduction of IgG
timeFrame: Measurements at baseline, during each treatment visit, ~1 week, ~1 month and ~3 months after start of treatment
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitätsklinikum Heidelberg in cooperation with Nierenzentrum Heidelberg
state: Baden-Wuerttemberg
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald, Zentrum für Innere Medizin, Klinik und Poliklinik für Innere Medizin B
state: Mecklenburg-Western Pomerania
city: Cologne
country: Germany
facility: Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin und Zentrum für Molekulare Medizin
state: North-Rhine Westphalia
city: Berlin
country: Germany
facility: Deutsches Herzzentrum Berlin, Klinik für Herz-, Thorax- und Gefäßchirurgie
Study officials:
affiliation: Heidelberg University
name: Ekkehard Grünig, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: