Study in Intensive Care Patients Regarding the Effect of Inhaled AP-301 After Primary Graft Dysfunction After Lung Transplantation

• Status: Completed
• Trial end date: 2015-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apeptico Forschung und Entwicklung GmbH
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Being a male or female recipient on the AKH's waiting list for primary single or double LuTX

• PGD score ≥ 1 within 72 hours after LuTX

• Informed consent is available

Exclusion Criteria:

• History of clinically relevant allergies or idiosyncrasies to AP301 or any other inactive ingredient(s) of the investigational product

• Postoperative ECMO support

• Paediatric /adolescent recipients (< 18 years)

• Lobar transplantation

• Retransplantation

• Combined solid organ transplants

• Participation in other drug trials