- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02096237
Extracorporeal SPecific IgE Removal From the Plasma of Allergic Asthma Patients (ESPIRA-study) (ESPIRA)
March 5, 2015 updated by: Fresenius Medical Care Deutschland GmbH
First in Man Trial to Investigate Safety and Efficacy of the New IgE Adsorber
In this study patients suffering from Immunoglobulin E (IgE) mediated asthma are treated with a method, called immune apheresis, that removes IgE from blood.
In order to achieve this blood is taken continuously from the patient and then separated into plasma and blood cells by centrifuge.
The plasma passes the new IgE adsorber where the IgE is specifically bound.
The "cleaned" plasma re-joined with the blood cells is given back to the patient.
In total each patient randomized to the apheresis group will undergo 3 treatments per week (i.e. 1 cycle) every 4 weeks over a time period of 3 months, that means 9 apheresis treatments in 3 cycles in total.
Study hypothesis is that the new IgE adsorber is capable of reducing IgE in plasma/serum by at least 50% measured before the first treatment in the first cycle and after the last treatment in the last treatment cycle.
The new adsorber can be safely used in patients.
A group of patients with conventional drug treatment and no apheresis treatment serves as control.
Study Overview
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Vienna, Austria, A-1090
- Medical University Vienna
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Signed Informed Consent
- Clinically relevant allergy to respiratory allergens confirmed by patient's history, skin-prick testing, IgE serology
- Allergic asthma (diagnosed by lung specialist)
- IgE concentration in blood at least 300 kilo Units (kU)/L
Exclusion Criteria:
- Participation in another trial within 30 days prior to enrolment
- Gravidity (pregnancy test prior to each treatment cycle)
- Intake of omalizumab
- Hepatitis or HIV or malignant disease
- Specific immunotherapy in the last 6 months
- Non-allergic asthma
- Auto-immune diseases
- Hypocalcaemia
- Intake of ACE-inhibitors (discontinuation according to half-time before treatment possible)
- Uncontrolled bleeding and coagulation disorders
- Severe cardiovascular disease
- Severe cardiac arrhythmias
- Severe systemic infection
- Unability to tolerate therapeutic apheresis procedures (hypersensitivity associated with previous apheresis sessions)
- Inadequate peripheral venous access
- Condition in which acute fluid shifts may cause congestive heart failure
- Established or suspected intra-cranial disease where fluid imbalance or pressure changes could exacerbate the disease
- Impaired renal function
- Clinically significant hypotension or borderline hypotension where a further drop in blood pressure could be harmful
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: apheresis, IgE adsorber
9 apheresis treatments with the new IgE adsorber in a period of 3 months with 3 cycles of 3 treatments each every month.
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Two plasma volumes of each patient in the apheresis group will be treated per session
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No Intervention: Conventional drug treatment
Patients treated with conventional asthma treatment as prescribed before study entry.
No intervention in prescription
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of IgE concentration in Plasma/Serum
Time Frame: Before first treatment (baseline) to after the last of 9 treatments over a time period of 3 months
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Decrease in IgE concentrations from before the first apheresis treatment (in the control group the first blood sampling) to after the last apheresis treatment after three months (in the control group last blood sampling after three months)
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Before first treatment (baseline) to after the last of 9 treatments over a time period of 3 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kurt Derfler, Prof. Dr., Dep. of Internal Medicine III, Nephrology and Dialysis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
July 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
March 21, 2014
First Submitted That Met QC Criteria
March 25, 2014
First Posted (Estimate)
March 26, 2014
Study Record Updates
Last Update Posted (Estimate)
March 6, 2015
Last Update Submitted That Met QC Criteria
March 5, 2015
Last Verified
March 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TA-IgE-01-A
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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