NCT02095626

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 21, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 26, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

November 18, 2019

Status Verified

November 1, 2019

Enrollment Period

1.7 years

First QC Date

March 21, 2014

Last Update Submit

November 15, 2019

Conditions

PGD Primary Graft Dysfunction

Keywords

Peptide

Outcome Measures

Primary Outcomes (1)

  • 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

    7 days

Secondary Outcomes (1)

  • EVLW

    7 days or until extubation

Study Arms (2)

AP301

EXPERIMENTAL

Treatment group

Drug: AP-301

Saline solution

PLACEBO COMPARATOR
Drug: saline solution

Interventions

AP-301DRUG

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

AP301
saline solutionDRUG

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

Saline solution

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Thoracic Surgery MedUni Vienna

Vienna, 1090, Austria

Location

MeSH Terms

Interventions

AP301 peptideSaline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

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

    Medical University of Vienna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2014

First Posted

March 26, 2014

Study Start

June 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

November 18, 2019

Record last verified: 2019-11

Locations

AU(1)