Study to investigate the effect of AP301 on treatment of primary graft dysfunction (PGD) after primary lung transplantatio
- Conditions
- Primary Graft Dysfunction (PGD) after lung transplantationTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2013-000716-21-AT
- Lead Sponsor
- Apeptico Forschung und Entwicklung GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method