At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 36 enrolled
Drug / intervention
Kamada-AAT for Inhalation, 80mg +2 moredrug
Likely dose
Kamada-AAT for Inhalation, 80mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase II, Double-Blind, Placebo-Controlled Study to Explore the ELF and Plasma Concentration as Well as Safety of Inhaled Alpha-1 Antitrypsin in Alpha-1 Antitrypsin Deficiency Subjects
In Brief
A Phase 2 clinical trial evaluating Kamada-AAT for Inhalation, 80mg, Placebo, and 1 other intervention for Alpha-1 Antitrypsin Deficiency. Completed, enrolled 36 participants across 2 sites.
Detailed Summary
To evaluate different doses of "Kamada-AAT for Inhalation" on the levels of alpha 1-proteinase inhibitor and other analytes in epithelial lining fluid (ELF) and serum and to assess the safety of the treatment in subjects with AAT Deficiency.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlpha-1 Antitrypsin Deficiency
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedDec 2013
Enrollment StartApr 2014
Primary CompletionFeb 2016
Study CompletionMay 2016
TodayJul 2026
First PostedDec 5, 2013
Enrollment StartApr 1, 2014
Primary CompletionFeb 1, 2016
Study CompletionMay 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 12.6 years ago
Interventions
Kamada-AAT for Inhalation, 80mgdrug
Placebodrug
Kamada-AAT for Inhalation, 160mgdrug