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

Not Applicable

Completed

• Conditions: Idiopathic Pulmonary Arterial Hypertension
• Interventions: Device: TheraSorb® - Ig flex

• Registration Number: NCT01613287
• Lead Sponsor: Miltenyi Biotec B.V. & Co. KG

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-05-29
• Study Start: 2012-06
• Study First Submitted QC: 2012-06-06
• Study First Posted: 2012-06-07
• Primary Completion: 2013-08
• Study Completion: 2013-11
• Status Verified: 2013-12
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Immunoadsorption	TheraSorb® - Ig flex	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

Primary Outcome Measures

Name	Time	Method
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).	Baseline, 3 months after therapy

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	~6months	The patients will be followed for the duration of the study participation, an expected average of 6 months.
occurrence and number of Adverse Events	~6 months	The patients will be followed for the duration of the study participation, an expected average of 6 months.
WHO functional classification	Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy	WHO functional classification of pulmonary hypertension (according to the Evian Symposium,1998, modified New York Heart Association (NYHA) Classification
Six-minute walk test (6MWT)	Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy
Quality of life questionnaires	Measurements at baseline, and after ~1 month, ~3 months, ~6 months	SF-36 EQ-5D™
Analysis of Hemodynamics by right heart catheterization: RAP, PAPm, CO, CI, SvO2; sPAP	Measurements at baseline, after ~3 months	(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	Measurements at baseline, during each treatment visit, ~1 week, ~1 month and ~3 months after start of treatment

Trial Locations

Locations (4)

Thoraxklinik am Universitätsklinikum Heidelberg in cooperation with Nierenzentrum Heidelberg; 🇩🇪 Heidelberg, Baden-Wuerttemberg, Germany

Deutsches Herzzentrum Berlin, Klinik für Herz-, Thorax- und Gefäßchirurgie; 🇩🇪 Berlin, Germany

Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin und Zentrum für Molekulare Medizin; 🇩🇪 Cologne, North-Rhine Westphalia, Germany

Universitätsmedizin Greifswald, Zentrum für Innere Medizin, Klinik und Poliklinik für Innere Medizin B; 🇩🇪 Greifswald, Mecklenburg-Western Pomerania, Germany