NCT01613287

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Miltenyi Biotec B.V. & Co. KG · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-08-01
• Completion: 2013-11-01
• First posted: 2012-06-07
• Last updated: 2020-07-10

Locations

4 sites across 1 country: Germany