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Pilot Study of Inhaled Solnatide for Primary Graft Dysfunction After Lung Transplantation
NCT02095626Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2013
- Primary completion
- Mar 2015
- Countries
- 1
- Sponsor
- APEPTICO
- Modality
- Modified Peptides, Native Peptides
- Drugs
- solnatide
- Conditions
- primary graft dysfunction (PGD)
01
Overview
Phase 2, randomised, double-blind trial in primary graft dysfunction (PGD) comparing AP301 with Placebo (2 arms). Primary endpoint: PaO2/FiO2 Ratio at 7 days. Started Jun 2013; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
AP301
Solnatide 87.6 mg inhaled every 12 hours
Placebo
Saline solution inhaled every 12 hours
03
Who it enrols
Adult lung transplant recipients with a PGD score ≥ 1 within 72 hours post-transplant, excluding those on ECMO or with lobar/combined transplants.
04
Endpoints
Primary
PaO2/FiO2 Ratio
Secondary
Extravascular Lung Water
05
Results
Primary endpoints met
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