A Phase 2 interventional study of AP-301 and saline solution in PGD Primary Graft Dysfunction, sponsored by Apeptico Forschung und Entwicklung GmbH. Completed at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-18.
Sponsored by Apeptico Forschung und Entwicklung GmbH · Phase 2, Interventional, and Treatment
The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.
26 studies on the registry are indexed under Primary Graft Dysfunction; 4 are open to participants now.
This study's enrollment of 20 is below the median of 47 across 11 interventional studies indexed under Primary Graft Dysfunction.
Browse Primary Graft Dysfunction studies →Apeptico Forschung und Entwicklung GmbH is the lead sponsor of 3 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment group
Drug: AP-301
Drug: saline solution
orally delivered doses of 87.6 mg AP301 (dose per subject, 5 ml nebulizer filling dose) are inhaled every 12 hours for a total of 7 days
placebo solution (0.9 % physiologic NaCl, 5 ml nebulizer filling dose) is inhaled every 12 hours for a total of 7 days
P/F ratio
The changes of the P/F ratio from T0 (time of PGD diagnosis) to day 7 of the treatment or to extubation of the patient
Time frame: 7 days
EVLW
Measurement of extravascular lung water
Time frame: 7 days or until extubation
The record gives a start of Jun 2013, a primary completion of Mar 2015 and a completion of Mar 2015. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: AP301 peptide
Apeptico Forschung und Entwicklung GmbH