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

Primary Purpose

PGD Primary Graft Dysfunction

Status

Completed

Phase

Phase 2

Locations

Austria

Study Type

Interventional

Intervention

AP-301

saline solution

About this trial

This is an interventional treatment trial for PGD Primary Graft Dysfunction focused on measuring Peptide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Division of Thoracic Surgery MedUni Vienna

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AP301

Saline solution

Arm Description

Treatment group

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

EVLW

Measurement of extravascular lung water

Full Information

NCT ID

NCT02095626

First Posted

March 21, 2014

Last Updated

November 15, 2019

Sponsor

Apeptico Forschung und Entwicklung GmbH

1. Study Identification

Unique Protocol Identification Number

NCT02095626

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Completed

Study Start Date

June 2013 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Apeptico Forschung und Entwicklung GmbH

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PGD Primary Graft Dysfunction

Keywords

Peptide

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AP301

Arm Type

Experimental

Arm Description

Treatment group

Arm Title

Saline solution

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

AP-301

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

saline solution

Intervention Description

placebo solution (0.9 % physiologic NaCl, 5 ml nebulizer filling dose) is inhaled every 12 hours for a total of 7 days

Primary Outcome Measure Information:

Title

P/F ratio

Description

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

Secondary Outcome Measure Information:

Title

EVLW

Description

Measurement of extravascular lung water

Time Frame

7 days or until extubation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Walter Klepetko, Univ.Prof.Dr.med.univ.

Organizational Affiliation

Medical University of Vienna

Official's Role

Principal Investigator

Facility Information:

Facility Name

Division of Thoracic Surgery MedUni Vienna

City

Vienna

ZIP/Postal Code

1090

Country

Austria

12. IPD Sharing Statement

Learn more about this trial

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

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