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Sponsors and Collaborators: |
Baxter Healthcare Corporation Arriva Pharmaceuticals, Inc. |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00157092 |
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.
Condition | Intervention | Phase |
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Alpha 1-Antitrypsin Deficiency |
Drug: Aerosolized, Recombinant Alpha 1-Antitrypsin |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety Study |
Official Title: | A Phase 1B/2A Study to Evaluate the Effect of Aerosolized, Recombinant Alpha 1-Antitrypsin on Epithelial Lining Fluid Analytes 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, Florida | |
Shands Hospital at the University of Florida | |
Gainesville, Florida, United States, 32610 |
Principal Investigator: | Mark Brantly, MD | University of Florida, Shands Hospital |
Study ID Numbers: | 410302 |
Study First Received: | September 8, 2005 |
Last Updated: | October 18, 2006 |
ClinicalTrials.gov Identifier: | NCT00157092 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Serine Proteinase Inhibitors Protein C Inhibitor Alpha 1-Antitrypsin Protein C |
Alpha 1-Antitrypsin Deficiency Connective Tissue Diseases Alpha 1-antitrypsin Deficiency Protease Inhibitors |
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 |