"Phase III, Efficacy and Safety of Kamada-AAT for Inhalation"

PHASE3RecruitingINTERVENTIONAL
Enrollment

220

Participants

Timeline

Start Date

November 25, 2019

Primary Completion Date

December 31, 2028

Study Completion Date

June 30, 2031

Conditions
Alpha 1-Antitrypsin Deficiency
Interventions
DRUG

Alpha 1-Antitrypsin

Kamada's alpha 1-antitrypsin product given by inhalation using the eFlow® electronic nebulizer manufactured by PARI Pharma GmbH

DRUG

Placebo

Preparation of NaCl in phosphate buffer solution with 0.01% TWEEN-80

Trial Locations (9)

Unknown

RECRUITING

University Hospital (UZ) Leuven, Leuven

RECRUITING

Tays Central Hospital, Tampere

D09 YD60

RECRUITING

Beaumont Hospital, Dublin

2333ZA

RECRUITING

Leiden University Medical Center (LUMC), Leiden

6532SZ

RECRUITING

Canisius Wilhelmina Hospital (CWZ), Nijmegen

SE-20502

RECRUITING

Skåne University Hospital, Malmo

B15 2GW

RECRUITING

University Hospitals Birmingham NHS Foundation Trust, Birmingham

EH16 4SA

RECRUITING

Royal Infirmary of Edinburgh, Edinburgh

SO16 6YD

RECRUITING

University Hospital Southampton NHS Foundation Trust, Southampton

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Syneos Health

OTHER

lead

Kamada, Ltd.

INDUSTRY