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Sponsored by: |
Baxter Healthcare Corporation |
---|---|
Information provided by: | Baxter Healthcare Corporation |
ClinicalTrials.gov Identifier: | NCT00242385 |
The primary purpose of this study is to characterize the pharmacokinetic profile of intravenous Aralast Fraction (Fr.) IV-1, a sterile, stable, lyophilized preparation of functionally intact human Alpha1- Proteinase Inhibitor (Alpha1-PI). This pharmacokinetic study will be a randomized controlled clinical trial with a cross-over design. Twenty-four subjects will be enrolled into the study. Overall study duration will be approximately 6-8 months.
Condition | Intervention | Phase |
---|---|---|
Alpha 1-Antitrypsin Deficiency |
Drug: ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (ARALAST Fr. IV-1) |
Phase I |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Active Control, Crossover Assignment, Pharmacokinetics Study |
Official Title: | Single-Dose, Double-Blind, Crossover Study to Evaluate the Pharmacokinetic Comparability of ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor (ARALAST Fr. IV-1) and ARALAST |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Laboratory results obtained at the screening visit, meeting the following criteria:
Exclusion Criteria:
Australia, South Australia | |
The Queen Elizabeth Hospital | |
Woodville, South Australia, Australia | |
Royal Adelaide Hospital | |
Adelaide, South Australia, Australia | |
Australia, Victoria | |
St. Vincent´s Hospital | |
Fitzroy, Victoria, Australia | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital | |
Nedlands, Western Australia, Australia | |
New Zealand | |
Christchurch Hospital, Canterbury Respiratory Research Group | |
Christchurch, New Zealand | |
Waikato Hospital, Respiratory Department | |
Hamilton, New Zealand | |
New Zealand, Auckland | |
Middlemore Hospital | |
Otahuhu, Auckland, New Zealand |
Principal Investigator: | Jeff Garrett, MD | Middlemore Hospital, Otahuhu, Auckland, New Zealand |
Study ID Numbers: | 460501 |
Study First Received: | October 19, 2005 |
Last Updated: | October 31, 2006 |
ClinicalTrials.gov Identifier: | NCT00242385 History of Changes |
Health Authority: | United States: Food and Drug Administration; Australia: Human Research Ethics Committee; New Zealand: Health and Disability Ethics Committees |
Severe congenital Alpha1-Proteinase Inhibitor (Alpha1-PI) deficiency |
Serine Proteinase Inhibitors Protein C Inhibitor Alpha 1-Antitrypsin Alpha 1-Antitrypsin Deficiency |
Connective Tissue Diseases Alpha 1-antitrypsin Deficiency Protease Inhibitors |
Serine Proteinase Inhibitors Alpha 1-Antitrypsin Molecular Mechanisms of Pharmacological Action Alpha 1-Antitrypsin Deficiency Trypsin Inhibitors |
Connective Tissue Diseases Enzyme Inhibitors Pharmacologic Actions Protease Inhibitors |