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

Idiopathic Pulmonary Arterial Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613287
• Other study ID #: M-2010-224
• Secondary ID: CIV-11-10-002861
• Status: Completed
• Phase: N/A
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: December 2013
• Source: Miltenyi Biomedicine GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 (ß-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

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Idiopathic Pulmonary Arterial Hypertension

Intervention

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.

Locations

Country	Name	City	State
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	Thoraxklinik am Universitätsklinikum Heidelberg in cooperation with Nierenzentrum Heidelberg	Heidelberg	Baden-Wuerttemberg

Sponsors (1)

Lead Sponsor	Collaborator
Miltenyi Biotec B.V. & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	all-cause mortality	The patients will be followed for the duration of the study participation, an expected average of 6 months.	~6months
Secondary	occurrence and number of Adverse Events	The patients will be followed for the duration of the study participation, an expected average of 6 months.	~6 months
Secondary	Six-minute walk test (6MWT)		Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy
Secondary	Quality of life questionnaires	SF-36 EQ-5D™	Measurements at baseline, and after ~1 month, ~3 months, ~6 months
Secondary	WHO functional classification	WHO functional classification of pulmonary hypertension (according to the Evian Symposium,1998, modified New York Heart Association (NYHA) Classification	Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy
Secondary	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.)	Measurements at baseline, after ~3 months
Secondary	Reduction of IgG		Measurements at baseline, during each treatment visit, ~1 week, ~1 month and ~3 months after start of treatment