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NCT00161707 · ClinicalTrials.gov registry record · Phase 1
Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency
A Phase 1 study, sponsored by Baxalta now part of Shire.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT00161707 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 40 participants.
The verdict
NCT00161707, a Phase 1 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha 1-antitrypsin deficiency. The subjects are randomized to receive placebo or one of 4 doses of rAAT. The 4 doses are tested in a consecutive manner from lowest to highest.
Interventions
- DRUG Aerosolized, Recombinant Alpha 1-Antitrypsin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2003-01-07 |
| Est. Completion | 2003-10-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00161707
The ClinicalTrials.gov registry entry for NCT00161707 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Aerosolized, Recombinant Alpha 1-Antitrypsin is the first listed.
NCT00161707 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00161707 about?
NCT00161707 is a clinical study titled "Safety Study of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency". The purpose of this randomized, double-blind, placebo-controlled study is to evaluate the short-term safety of inhaled recombinant alpha 1-antitrypsin (rAAT) in subjects with alpha 1-antitrypsin deficiency. The subjects are randomized to receive placebo or one of 4 doses of rAAT. The 4 doses are tes...
What is the current status of trial NCT00161707?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2003-01-07. Estimated completion is 2003-10-01.
What interventions are being tested in trial NCT00161707?
The interventions under investigation include: Aerosolized, Recombinant Alpha 1-Antitrypsin (DRUG).
Who is sponsoring clinical trial NCT00161707?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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