Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Baxalta now part of Shire.
NCT00161707 is a Phase 1 study that has completed, run by Baxalta now part of Shire. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT00161707 record still lists
NCT00161707 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 1 intervention - of which Aerosolized, Recombinant Alpha 1-Antitrypsin is the first listed.
NCT00161707 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00161707's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01306019 · 40 participants · Phase 1
Lentiviral Gene Transfer for Treatment of Children Older Than Two Years of Age With X-Linked Severe Combined Immunodeficiency (XSCID)
- NCT01608152 · 40 participants
Development of a Video Game for the Improvement of Outcomes in Stem Cell Transplant Survivors
- NCT01668082 · 40 participants · NA
An Investigation of Brain Tumor Metabolism in Patients Undergoing Surgical Resection
- NCT02015013 · 40 participants · Phase 2
Hematopoietic Stem Cell Mobilization in Idiopathic CD4 Lymphocytopenia Patients and Healthy Controls for the Study of T Cell Maturation and Trafficking in Murine Models
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI