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NCT00377416 · ClinicalTrials.gov registry record · Early Phase 1

Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin Deficiency

A Early Phase 1 study, sponsored by University of Massachusetts, Worcester.

Completed
Registry status
Early Phase 1
Development phase
12
Enrollment target

NCT00377416 is a Early Phase 1 study that has completed, run by University of Massachusetts, Worcester. The registered enrollment target is 12 participants.

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The verdict

NCT00377416, a Early Phase 1 study, has completed, sponsored by University of Massachusetts, Worcester.

COMPLETED
Registry status
Early Phase 1
Development phase
12 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 so that the AAT protein is produced at normal levels. This study will evaluate the safety of the experimental gene transfer procedure in individuals with AAT deficiency.

Interventions

  • GENETIC rAAV2-CB-hAAT Gene Vector

Trial Details

FieldValue
Enrollment Target 12 participants
Start Date 2004-03
Est. Completion 2020-01
Phase Early Phase 1

What the Registry Record Tells You About NCT00377416

The ClinicalTrials.gov registry entry for NCT00377416 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 12 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 rAAV2-CB-hAAT Gene Vector is the first listed.

NCT00377416 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00377416 about?

NCT00377416 is a clinical study titled "Experimental Gene Transfer Procedure to Treat Alpha 1-Antitrypsin 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 so that the AAT protein is produced at normal levels. This study will evaluate the safety of ...

What is the current status of trial NCT00377416?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 12 participants. The study started on 2004-03. Estimated completion is 2020-01.

What interventions are being tested in trial NCT00377416?

The interventions under investigation include: rAAV2-CB-hAAT Gene Vector (GENETIC).

Who is sponsoring clinical trial NCT00377416?

This trial is sponsored by University of Massachusetts, Worcester, which has 240 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.