Who is sponsoring APPIRED-II?

APPIRED-II is sponsored by Alloksys Life Sciences B.V..

What condition does APPIRED-II study?

APPIRED-II studies Inflammation.

What drugs are being tested in APPIRED-II?

Interventions: bIAP bolus and 8h infusion, placebo bolus and 8h infusion.

What is the status of APPIRED-II?

APPIRED-II is currently COMPLETED.

Last reviewed 2016-09-19 · How we verify

A Randomized, Double-blind, Placebo-controlled Phase IIIa Study on bIAP, an Anti-inflammatory Moiety, in Patients Undergoing Combined Aortic Valve Replacement and Coronary Artery Bypass Grafting (APPIRED-II)

NCT01144611 Phase 3 COMPLETED

This multi-centre prospective, randomised, double-blind, placebo-controlled study is designed to evaluate the efficacy and safety of bovine intestinal alkaline phosphatase (bIAP) in reducing the pro-inflammatory post-surgical responses and thereby preserving organ functions in patients undergoing invasive cardiac surgery: combined aortic valve replacement and coronary artery bypass grafting.

Details

Lead sponsor	Alloksys Life Sciences B.V.
Phase	Phase 3
Status	COMPLETED
Enrolment	53
Start date	2010-04
Completion	2013-12

Conditions

Inflammation

Interventions

bIAP bolus and 8h infusion
placebo bolus and 8h infusion

Primary outcomes

TNF-alpha — one day before till 5 days post surgery
as indicator of post-surgical inflammatory response

Countries

Netherlands