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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: Clinical Trial Phase 4 study, sponsored by Baxalta now part of Shire.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Change in quality of life survey response as measured using the SF-36 questionnaire. Scores range from 0 to 100 with higher scores representing better health. There is no total overall score; scoring is done for both subscores and summary scores. The raw data from the SF-36 items were transformed to norm based scores for each of the 8 HRQoL/SF-36 health domain scores. The data transformation process was based on: Ware et al. How to Score Version 2 of the SF-36® Health Survey. Lincoln, RI: Qualit
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 |
Why NCT00313144 stopped before completion
NCT00313144 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (75% lower).
The record links to 0 conditions, and to 1 intervention - of which ARALAST Alpha1-Proteinase Inhibitor is the first listed.
NCT00313144 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00313144's enrollment target sits among peer trials
127 639th of 2000 higher than 1,355 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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