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

NCT01613287 | Completed DMC

• 2 other identifiers: M-2010-224CIV-11-10-002861
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 4

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.

Conditions

Idiopathic Pulmonary Arterial Hypertension

Keywords

Pulmonary Hypertension; Pulmonary Arterial Hypertension; TheraSorb; immunoadsorption

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• all-cause mortality

  ~6months

• occurrence and number of Adverse Events

  ~6 months

• 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

• WHO functional classification

  Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy

Study Arms (1)

Immunoadsorption

EXPERIMENTAL

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

Interventions

TheraSorb® - Ig flex DEVICE

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.

Also known as: Immunoadsorption

Immunoadsorption

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Pregnancy and/or lactation
• Contraindication for right heart catheterization
• 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

Sponsors & Collaborators

• Miltenyi Biotec B.V. & Co. KG: lead

Study Sites (4)

Thoraxklinik am Universitätsklinikum Heidelberg in cooperation with Nierenzentrum Heidelberg

Heidelberg, Baden-Wurttemberg, 69126/ 69120, Germany

Location

Universitätsmedizin Greifswald, Zentrum für Innere Medizin, Klinik und Poliklinik für Innere Medizin B

Greifswald, Mecklenburg-Vorpommern, 17475, Germany

Location

Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin und Zentrum für Molekulare Medizin

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Deutsches Herzzentrum Berlin, Klinik für Herz-, Thorax- und Gefäßchirurgie

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Pulmonary Arterial Hypertension

Interventions

Plasmapheresis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Blood Component Removal; Therapeutics; Sorption Detoxification; Extracorporeal Circulation; Surgical Procedures, Operative

Study Officials

• Ekkehard Grünig, Prof. Dr.

  Heidelberg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2012
• First Posted: June 7, 2012
• Study Start: June 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: November 1, 2013
• Last Updated: July 10, 2020

Record last verified: 2013-12

Locations

DE (4)