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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT02096237
Study type Interventional
Source Fresenius Medical Care Deutschland GmbH
Contact
Status Completed
Phase N/A
Start date December 2013
Completion date November 2014

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