Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Baxter Healthcare Corporation Arriva Pharmaceuticals, Inc. |
---|---|
Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00161707 |
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 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | 410103 |
Study First Received: | September 8, 2005 |
Last Updated: | October 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00161707 |
Health Authority: | United States: Food and Drug Administration |
Protein C Inhibitor Alpha 1-Antitrypsin Protein C |
Alpha 1-Antitrypsin Deficiency Alpha 1-antitrypsin deficiency Connective Tissue Diseases |
Serine Proteinase Inhibitors Molecular Mechanisms of Pharmacological Action Trypsin Inhibitors |
Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |