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Sponsored by: |
Baxter Healthcare Corporation |
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Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00396006 |
The purpose of this study is to evaluate the effects of weekly augmentation therapy with ARALAST Fr IV-1 on epithelial lining fluid (ELF) alpha 1-proteinase inhibitor levels and other ELF analytes and to assess the safety of the treatment. Eligible subjects with a diagnosis of severe congenital alpha 1-antitrypsin deficiency will receive 8 consecutive weekly treatments with 60 mg/kg/week of functional ARALAST Fr IV-1 administered intravenously. The efficacy and safety assessments will include two bronchoscopies with bronchoalveolar lavage on study initiation and on study termination and multiple imaging and laboratory safety assessments. Each subject will participate for a minimum of 12 weeks.
Condition | Intervention | Phase |
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Alpha 1-Antitrypsin Deficiency |
Drug: ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (ARALAST Fr. IV-1) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | The Effect of Augmentation Therapy With ARALAST Fraction IV-1 (Fr IV-1) Alpha1-Proteinase Inhibitor (PI) on the Level of Alpha 1-PI and Other Analytes in the Bronchoalveolar Epithelial Lining Fluid (ELF) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Pulmonary functions at screening meeting the following criteria:
Laboratory results obtained at the screening visit, meeting the following criteria:
Exclusion Criteria:
Australia, South Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia, 5000 | |
Australia, Victoria | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital | |
Nedlands, Western Australia, Australia, 6009 | |
New Zealand | |
Waikato Hospital | |
Hamilton, New Zealand | |
New Zealand, Auckland | |
Middlemore Hospital | |
Otahuhu, Auckland, New Zealand |
Study Director: | Baxter BioScience Investigator, MD | Baxter Healthcare Corporation |
Study ID Numbers: | 460502 |
Study First Received: | November 3, 2006 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00396006 |
Health Authority: | United States: Food and Drug Administration |
Protein C Inhibitor Alpha 1-Antitrypsin 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 |