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NCT00157092 · ClinicalTrials.gov registry record · Phase 1
Study of the Effect of Aerosolized, Recombinant Alpha 1-Antitrypsin on Epithelial Lining Fluid Analytes 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
- 15
- Enrollment target
NCT00157092 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 15 participants.
The verdict
NCT00157092, a Phase 1 study, has completed, sponsored by Baxalta now part of Shire.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 15 participants
- Enrollment target
Study Summary
The study was a Phase 1B/2A, uncontrolled, open-label, single-center study in individuals with congenital AAT (alpha 1-antitrypsin) deficiency. A baseline bronchoscopy with bronchoalveolar lavage (BAL) was performed 3 to a maximum of 4 weeks prior to the first administration of study drug. Fifteen eligible subjects were randomized to receive 1 of 3 dosing regimens of rAAT (100 mg daily, 100 mg twice daily, or 200 mg daily) administered via nebulization for 7 consecutive days. A post-treatment nadir BAL was obtained on study Day 8 (12 hours after last dose for subjects who receive drug therapy twice daily and 24 hours after the last dose for subjects who receive study product daily). BALs were conducted in the same lung lobe/segment. Follow-up visits took place on Day 15 and Day 36.
Interventions
- DRUG Aerosolized, Recombinant Alpha 1-Antitrypsin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2004-03-01 |
| Est. Completion | 2004-10-14 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00157092
The ClinicalTrials.gov registry entry for NCT00157092 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 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.
NCT00157092 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00157092 about?
NCT00157092 is a clinical study titled "Study of the Effect of Aerosolized, Recombinant Alpha 1-Antitrypsin on Epithelial Lining Fluid Analytes in Subjects With Alpha 1-Antitrypsin Deficiency". The study was a Phase 1B/2A, uncontrolled, open-label, single-center study in individuals with congenital AAT (alpha 1-antitrypsin) deficiency. A baseline bronchoscopy with bronchoalveolar lavage (BAL) was performed 3 to a maximum of 4 weeks prior to the first administration of study drug. Fifteen e...
What is the current status of trial NCT00157092?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 2004-03-01. Estimated completion is 2004-10-14.
What interventions are being tested in trial NCT00157092?
The interventions under investigation include: Aerosolized, Recombinant Alpha 1-Antitrypsin (DRUG).
Who is sponsoring clinical trial NCT00157092?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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