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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 10, 2006 | ||||
| Last Updated Date | June 25, 2009 | ||||
| Start Date ICMJE | June 2006 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
HRQoL and HCRU data [ Time Frame: At study completion ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
HRQoL and HCRU data [ Time Frame: at study completion ] | ||||
| Change History | Complete list of historical versions of study NCT00313144 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Aralast alpha1-Proteinase Inhibitor Surveillance Study | ||||
| Official Title ICMJE | ARALAST alpha1-Proteinase Inhibitor (α1-PI) Surveillance Study | ||||
| Brief Summary | The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of AAT-deficient subjects who are initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related quality of life (HRQoL), healthcare resource utilization (HCRU), and various laboratory analyses to evaluate the safety of long-term administration of ARALAST. Up to 120 subjects will be enrolled and assessed for HRQoL and HCRU at baseline and every 6-months thereafter, for 2 years. A subset of subjects will be enrolled into the blood draw portion of the study, which will also include assessments of antibodies to ARALAST, and chemistry panel. Subjects will be treated according to the prescribing (attending) physician's instructions based on the prescribing information given in the ARALAST package insert. |
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| Detailed Description | |||||
| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE | Alpha 1-Antitrypsin Deficiency | ||||
| Intervention ICMJE | Drug: ARALAST Fraction IV-1 Alpha1-Proteinase Inhibitor | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Completion Date | May 2009 | ||||
| Primary Completion Date | December 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00313144 | ||||
| Responsible Party | Nancy Sullivan, Clinical Project Manager, Baxter Healthcare Corporation | ||||
| Study ID Numbers ICMJE | 450501 | ||||
| Study Sponsor ICMJE | Baxter Healthcare Corporation | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Baxter Healthcare Corporation | ||||
| Verification Date | June 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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