Idiopathic Pulmonary Arterial HypertensionNCT01613287
Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension
A study testing TheraSorb® - Ig flex in people with Idiopathic Pulmonary Arterial Hypertension, run by Miltenyi Biotec B.V. & Co. KG at 4 sites in Germany.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Idiopathic Pulmonary Arterial Hypertension
- What is being tested?
- TheraSorb® - Ig flex
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesGermany
- Study dates
- Jun 2012to Nov 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Deutsches Herzzentrum Berlin, Klinik für Herz-, Thorax- und Gefäßchirurgie
Berlin, 13353
Herzzentrum der Universität zu Köln, Klinik III für Innere Medizin und Zentrum für Molekulare Medizin
Cologne, North Rhine-Westphalia, 50937
Universitätsmedizin Greifswald, Zentrum für Innere Medizin, Klinik und Poliklinik für Innere Medizin B
Greifswald, Mecklenburg-Vorpommern, 17475
Thoraxklinik am Universitätsklinikum Heidelberg in cooperation with Nierenzentrum Heidelberg
Heidelberg, Baden-Wurttemberg, 69126/ 69120
About this study
Official title: A Clinical Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension
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.
- Being tested
- TheraSorb® - Ig flex
- Keywords
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, TheraSorb, immunoadsorption
- Medical subject headings
- Familial Primary Pulmonary Hypertension, Hypertension, Pulmonary, Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraSorb® - Ig flexDevice
Also called Immunoadsorption
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: TheraSorb® - Ig flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline, 3 months after therapy
Secondary outcomes (7)
all-cause mortality
The patients will be followed for the duration of the study participation, an expected average of 6 months.
Measured: ~6months
occurrence and number of Adverse Events
The patients will be followed for the duration of the study participation, an expected average of 6 months.
Measured: ~6 months
Six-minute walk test (6MWT)
Measured: Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy
Quality of life questionnaires
SF-36 EQ-5D™
Measured: Measurements at baseline, and after ~1 month, ~3 months, ~6 months
WHO functional classification
WHO functional classification of pulmonary hypertension (according to the Evian Symposium,1998, modified New York Heart Association (NYHA) Classification
Measured: Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy
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.)
Measured: Measurements at baseline, after ~3 months
Reduction of IgG
Measured: Measurements at baseline, during each treatment visit, ~1 week, ~1 month and ~3 months after start of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionAug 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Pulmonary Arterial HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Miltenyi Biotec B.V. & Co. KG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ekkehard Grünig, Prof. Dr., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613287
- Sponsor's protocol ID
- M-2010-224
- Other IDs
- CIV-11-10-002861
- Status last verified
- Dec 2013
- First submitted
- 29 May 2012
- Last updated
- 10 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Proof of Concept Study of IMMUNOadsorption Therapy in Patients With Idiopathic Pulmonary Arterial Hypertension
- ClinicalTrials.gov ID
- NCT01613287
- Acronym / sponsor ID
- M-2010-224
- Keywords
- Pulmonary Hypertension, Pulmonary Arterial Hypertension, TheraSorb, immunoadsorption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Miltenyi Biotec B.V. & Co. KGIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immunoadsorption | Experimental | Device: TheraSorb® - Ig flexPatients 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 |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheraSorb® - Ig flexAlso: ImmunoadsorptionTheraSorb® 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. | Device | Immunoadsorption |
Primary outcome
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
7 secondary outcomes
all-cause mortality
Time frame: ~6months
occurrence and number of Adverse Events
Time frame: ~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
Quality of life questionnaires
Time frame: Measurements at baseline, and after ~1 month, ~3 months, ~6 months
WHO functional classification
Time frame: Measurements at baseline, ~1 week, ~1 month, ~3 months and ~6 months after start of therapy
Analysis of Hemodynamics by right heart catheterization: RAP, PAPm, CO, CI, SvO2; sPAP
Time frame: Measurements at baseline, after ~3 months
Reduction of IgG
Time frame: Measurements at baseline, during each treatment visit, ~1 week, ~1 month and ~3 months after start of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekkehard Grünig, Prof. Dr. principal investigator
Heidelberg University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TheraSorb® - Ig flex in people with Idiopathic Pulmonary Arterial Hypertension, run by Miltenyi Biotec B.V. & Co. KG at 4 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). (time frame: Baseline, 3 months after therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2020.