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| Sponsor: | Baxter Healthcare Corporation |
|---|---|
| Collaborator: |
Arriva Pharmaceuticals, Inc. |
| Information provided by: | Baxter Healthcare Corporation |
| ClinicalTrials.gov Identifier: | NCT00161707 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alpha 1-Antitrypsin Deficiency |
Drug: Aerosolized, Recombinant Alpha 1-Antitrypsin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety Study |
| Official Title: | Phase I Safety Investigation of an Aerosolized, Recombinant Alpha 1-Antitrypsin in Subjects With Alpha 1-Antitrypsin Deficiency |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Colorado | |
| National Jewish Medical and Research Center | |
| Denver, Colorado, United States, 80206 | |
| United States, Florida | |
| Shands Hospital at the University of Florida | |
| Gainesville, Florida, United States, 32610 | |
| United States, Ohio | |
| Cleveland Clinic Foundation, Department of Pulmonary and Critical Care Medicine | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Texas | |
| The University of Texas Health Science Center at Tyler | |
| Tyler, Texas, United States, 75708-3154 | |
| Principal Investigator: | Mark Brantly, MD | Shands Hospital at the University of Florida |
More Information
| Study ID Numbers: | 410103 |
| Study First Received: | September 8, 2005 |
| Last Updated: | October 18, 2006 |
| ClinicalTrials.gov Identifier: | NCT00161707 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Serine Proteinase Inhibitors Protein C Inhibitor Alpha 1-Antitrypsin Molecular Mechanisms of Pharmacological Action Alpha 1-Antitrypsin Deficiency |
Trypsin Inhibitors Connective Tissue Diseases Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |