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NCT00873782 · ClinicalTrials.gov registry record · Phase 1

Safety Study of Transvenous Limb Perfusion in Human Muscular Dystrophy

A Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
Phase 1
Development phase
16
Enrollment target

NCT00873782: Completed Phase 1 study, sponsored by University of North Carolina, Chapel Hill.

NCT00873782 is a Phase 1 study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 16 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00873782, a Phase 1 study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
Phase 1
Development phase
16 participants
Enrollment target

Study Summary

Muscular dystrophies are inherited disorders in which the skeletal and heart muscles become progressively weaker, sometimes leading to permanent disability. Current treatments aim to control symptoms as much as possible, but there is no cure. Gene therapy, in which defective genes causing the disorder are corrected, is a potential treatment option and is in the process of being developed for muscular dystrophies. This study will determine the safety and feasibility of a particular delivery method for gene therapy that could be used in the future to treat people with muscular dystrophies. Only normal saline, and no active treatment, will be used in this study.

Primary Outcome

Number of Participants with all of the following three: 1. Unchanged Doppler ultrasound to assess venous and arterial damage pre-and post perfusion based on report 2. Without clinically significant changes in electrodiagnostic testing using standard neurographic techniques pre-and post perfusion:\>1 mSec change in baseline distal motor latency; \<75% baseline compound muscle action potential amplitude, \<75% baseline conduction velocity, sensory nerve action potential 3. Without clinically sign

Interventions

  • OTHER Retrograde high pressure transvenous perfusion with normal saline

Trial Details

FieldValue
Enrollment Target 16 participants
Start Date 2009-03
Est. Completion 2014-02
Phase Phase 1

What the finished NCT00873782 record still lists

NCT00873782 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (73% lower).

The record links to 0 conditions, and to 1 intervention - of which Retrograde high pressure transvenous perfusion with normal saline is the first listed.

NCT00873782 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00873782 about?

NCT00873782 is a clinical study titled "Safety Study of Transvenous Limb Perfusion in Human Muscular Dystrophy". Muscular dystrophies are inherited disorders in which the skeletal and heart muscles become progressively weaker, sometimes leading to permanent disability. Current treatments aim to control symptoms as much as possible, but there is no cure. Gene therapy, in which defective genes causing the disord...

What is the current status of trial NCT00873782?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 16 participants. The study started on 2009-03. Estimated completion is 2014-02.

What interventions are being tested in trial NCT00873782?

The interventions under investigation include: Retrograde high pressure transvenous perfusion with normal saline (OTHER).

Who is sponsoring clinical trial NCT00873782?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00873782's enrollment target sits among peer trials

16 1786th of 2000 higher than 203 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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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Source: ClinicalTrials.gov NCT00873782, the US trial registry maintained by the National Library of Medicine. NCT00873782 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.