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NCT01054339 · ClinicalTrials.gov registry record · Phase 2
Safety & Efficacy Study of rAAV1-CB-hAAT for Alpha-1 Antitrypsin Deficiency
A Phase 2 study of Alpha-1 Antitrypsin Deficiency, sponsored by Beacon Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 9
- Enrollment target
- 4
- Study locations
NCT01054339 is a Phase 2 study of Alpha-1 Antitrypsin Deficiency that has completed, run by Beacon Therapeutics. The registered enrollment target is 9 participants, below the 3,077-participant average among 18 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (100% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT01054339, a Phase 2 study of Alpha-1 Antitrypsin Deficiency, has completed, sponsored by Beacon Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 9 participants
- Enrollment target
- 4
- Study locations
Study Summary
Assessment of the safety and efficacy of intramuscular (IM) administration of a recombinant adenoassociated virus (rAAV) alpha-1 antitrypsin (AAT) vector (rAAV1-CB-hAAT) in AAT-deficient adults at three dosage levels \[6.0 × 10e11, 1.9 × 10e12 and 6.0 × 10e12 vector genome particles (vg) per kg body weight\]. Funding Sources - The FDA Office of Orphan Products Development and NIH National Heart, Lung, and Blood Institute
Conditions Studied
Interventions
- DRUG rAAV1-CB-hAAT
Study Locations (4)
Colorado
- National Jewish Health - Denver
Massachusetts
- University of Massachusetts Medical Center - Worcester
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Other
- Beaumont Hospital - Dublin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2010-06 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01054339
The ClinicalTrials.gov registry entry for NCT01054339 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,077-participant average among 18 other Alpha-1 Antitrypsin Deficiency trials with a reported enrollment target (100% lower). The listed sponsor is Beacon Therapeutics, which has 12 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Alpha-1 Antitrypsin Deficiency appearing as the primary indexed condition, and to 1 intervention - of which rAAV1-CB-hAAT is the first listed.
NCT01054339 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Colorado, Massachusetts, Ohio.
Frequently Asked Questions
What is clinical trial NCT01054339 about?
NCT01054339 is a clinical study titled "Safety & Efficacy Study of rAAV1-CB-hAAT for Alpha-1 Antitrypsin Deficiency". Assessment of the safety and efficacy of intramuscular (IM) administration of a recombinant adenoassociated virus (rAAV) alpha-1 antitrypsin (AAT) vector (rAAV1-CB-hAAT) in AAT-deficient adults at three dosage levels \[6.0 × 10e11, 1.9 × 10e12 and 6.0 × 10e12 vector genome particles (vg) per kg body...
What is the current status of trial NCT01054339?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 9 participants. The study started on 2010-06. Estimated completion is 2015-10.
What conditions does trial NCT01054339 study?
This clinical trial studies the following conditions: Alpha-1 Antitrypsin Deficiency.
What interventions are being tested in trial NCT01054339?
The interventions under investigation include: rAAV1-CB-hAAT (DRUG).
Who is sponsoring clinical trial NCT01054339?
This trial is sponsored by Beacon Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01054339 being conducted?
This trial has 4 study locations across Colorado, Massachusetts, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.