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NCT00430768 · ClinicalTrials.gov registry record · Phase 1
Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin (AAT) Deficiency
A Phase 1 study, sponsored by University of Massachusetts, Worcester.
- Completed
- Registry status
- Phase 1
- Development phase
- 9
- Enrollment target
NCT00430768 is a Phase 1 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 9 participants.
The verdict
NCT00430768, a Phase 1 study, has completed, sponsored by University of Massachusetts, Worcester.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 9 participants
- Enrollment target
Study Summary
Individuals with a deficiency of the alpha 1-antitrypsin (AAT) protein are at risk for developing emphysema and liver damage. Researchers have developed a way to introduce normal AAT genes into muscle cells with the expectation that the AAT protein may be produced at normal levels. This study will evaluate the safety of the experimental gene transfer procedure in individuals with AAT deficiency. The study will also determine what dose may be required to achieve normal levels of AAT.
Interventions
- BIOLOGICAL rAAV1-CB-hAAT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2006-02 |
| Est. Completion | 2015-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00430768
The ClinicalTrials.gov registry entry for NCT00430768 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Massachusetts, Worcester, which has 240 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which rAAV1-CB-hAAT is the first listed.
NCT00430768 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00430768 about?
NCT00430768 is a clinical study titled "Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin (AAT) Deficiency". Individuals with a deficiency of the alpha 1-antitrypsin (AAT) protein are at risk for developing emphysema and liver damage. Researchers have developed a way to introduce normal AAT genes into muscle cells with the expectation that the AAT protein may be produced at normal levels. This study will e...
What is the current status of trial NCT00430768?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 9 participants. The study started on 2006-02. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00430768?
The interventions under investigation include: rAAV1-CB-hAAT (BIOLOGICAL).
Who is sponsoring clinical trial NCT00430768?
This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.
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