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NCT02001688 · ClinicalTrials.gov registry record · Phase 2
Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for Inhalation"
A Phase 2 study, sponsored by Kamada.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT02001688: Completed Phase 2 study, sponsored by Kamada.
NCT02001688 is a Phase 2 study that has completed, run by Kamada. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02001688, a Phase 2 study, has completed, sponsored by Kamada.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study 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.
Primary Outcome
Patients underwent bronchoalveolar lavage (BAL) prior to initiation of drug and then again after 3 months. Concentration of AAT in the BAL was measured by an enzyme linked immunosorbent assay (ELISA) specific for the normal form of AAT (piM). Urea was also measured in order to determine the dilution factor of the BAL fluid and calculate the concentration of AAT in the ELF.
Interventions
- DRUG Placebo
- DRUG Kamada-AAT for Inhalation, 80mg
- DRUG Kamada-AAT for Inhalation, 160mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
What the finished NCT02001688 record still lists
NCT02001688 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02001688 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02001688 about?
NCT02001688 is a clinical study titled "Phase II, Safety and Efficacy Study of Kamada-alpha-1-antitrypsin (AAT) for Inhalation"". 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.
What is the current status of trial NCT02001688?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2014-04. Estimated completion is 2016-05.
What interventions are being tested in trial NCT02001688?
The interventions under investigation include: Placebo (DRUG), Kamada-AAT for Inhalation, 80mg (DRUG), Kamada-AAT for Inhalation, 160mg (DRUG).
Who is sponsoring clinical trial NCT02001688?
This trial is sponsored by Kamada, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02001688's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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