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NCT00313144 · ClinicalTrials.gov registry record · Phase 4
Aralast alpha1-proteinase Inhibitor Surveillance Study
A Phase 4 study, sponsored by Baxalta now part of Shire.
- Terminated
- Registry status
- Phase 4
- Development phase
- 127
- Enrollment target
NCT00313144 is a Phase 4 study that was terminated before completion, run by Baxalta now part of Shire. The registered enrollment target is 127 participants.
The verdict
NCT00313144, a Phase 4 study, was terminated before completion, sponsored by Baxalta now part of Shire.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 127 participants
- Enrollment target
Study Summary
The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (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.
Interventions
- DRUG ARALAST Alpha1-Proteinase Inhibitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2006-06-09 |
| Est. Completion | 2009-05-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00313144
The ClinicalTrials.gov registry entry for NCT00313144 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 127 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baxalta now part of Shire, which has 74 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which ARALAST Alpha1-Proteinase Inhibitor is the first listed.
NCT00313144 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00313144 about?
NCT00313144 is a clinical study titled "Aralast alpha1-proteinase Inhibitor Surveillance Study". The primary objectives of this Phase 4, open label, prospective U.S. surveillance study are to evaluate the health outcomes of Alpha 1-Antitrypsin (AAT)-deficient subjects who are initiating treatment with ARALAST on patient-related outcomes (PRO), i.e., health-related quality of life (HRQoL), healt...
What is the current status of trial NCT00313144?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 127 participants. The study started on 2006-06-09. Estimated completion is 2009-05-01.
What interventions are being tested in trial NCT00313144?
The interventions under investigation include: ARALAST Alpha1-Proteinase Inhibitor (DRUG).
Who is sponsoring clinical trial NCT00313144?
This trial is sponsored by Baxalta now part of Shire, which has 74 total clinical trials registered on ClinicalTrials.gov.
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