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Clinical Trials/EUCTR2013-000716-21-AT
EUCTR2013-000716-21-AT
Active, not recruiting
Not Applicable

Pilot study to investigate the clinical effect of orally inhaled AP301 on treatment of primary graft dysfunction (PGD) in mechanically ventilated patients after primary lung transplantation

Apeptico Forschung und Entwicklung GmbH0 sitesApril 30, 2013
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Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Not specified
Sponsor
Apeptico Forschung und Entwicklung GmbH
Status
Active, not recruiting
Last Updated
11 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 30, 2013
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility 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
  • •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

Outcomes

Primary Outcomes

Not specified

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