Clinical trial
Pharmacokinetic Study of ARALAST (Human Alpha1- PI)
NCT00242385 · Baxalta now part of Shire, Industry · Completed
Key facts
| NCT number | NCT00242385 |
|---|---|
| Title | Pharmacokinetic Study of ARALAST (Human Alpha1- PI) |
| 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 |
| Lead sponsor | Baxalta now part of Shire, Industry |
| Collaborators | Baxter Healthcare, Ltd. (New Zealand), Baxter Healthcare Pty. Ltd. (Australia) Industry |
| Status | Completed |
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Alpha 1-Antitrypsin Deficiency |
| Intervention type | Biological |
| Interventions | Dose of 60 mg/kg Fraction IV-1 Alpha1-Proteinase Inhibitor, Dose of 60 mg/kg alpha1-proteinase inhibitor |
| Enrollment | 25 |
| Start date | Dec 20, 2005 |
| Primary completion | Jun 5, 2006 |
| Completion | Jun 5, 2006 |
| First posted | Oct 20, 2005 |
| Last update posted | May 13, 2021 |
| Countries | Australia, New Zealand |
At a glance
- Yes Results posted
- None Linked FDA submissions
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date: