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NCT00350714 · ClinicalTrials.gov registry record · Phase 2

BreathID Multi-center HCV Liver Breath Test Study

A Phase 2 study, sponsored by Meridian Bioscience.

Terminated
Registry status
Phase 2
Development phase
75
Enrollment target

NCT00350714: Clinical Trial Phase 2 study, sponsored by Meridian Bioscience.

NCT00350714 is a Phase 2 study that was terminated before completion, run by Meridian Bioscience. The registered enrollment target is 75 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00350714, a Phase 2 study, was terminated before completion, sponsored by Meridian Bioscience.

TERMINATED
Registry status
Phase 2
Development phase
75 participants
Enrollment target

Study Summary

The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver fibrosis (\>2 in METAVIR) in patients with chronic HCV liver disease.The test is a breath-test using a free-standing device (BreathID®) that measures metabolization of a 13C-labeled substrate (13C-methacetin) in real time.

Primary Outcome

13 C Lebeled substrate is metabolized by Liver and reflects liver function. It is hypothesized that this correlated to liver fibrosis

Interventions

  • OTHER MBT and BreathID

Trial Details

FieldValue
Enrollment Target 75 participants
Start Date 2006-07
Est. Completion 2007-02
Phase Phase 2
Meridian Bioscience

19 total trials

Why NCT00350714 stopped before completion

NCT00350714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% lower).

The record links to 0 conditions, and to 1 intervention - of which MBT and BreathID is the first listed.

NCT00350714 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00350714 about?

NCT00350714 is a clinical study titled "BreathID Multi-center HCV Liver Breath Test Study". The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver fibrosis (\>2 in METAVIR) in patients with chronic HCV liver disease.The test is a breath-test using a free-standing devi...

What is the current status of trial NCT00350714?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 75 participants. The study started on 2006-07. Estimated completion is 2007-02.

What interventions are being tested in trial NCT00350714?

The interventions under investigation include: MBT and BreathID (OTHER).

Who is sponsoring clinical trial NCT00350714?

This trial is sponsored by Meridian Bioscience, which has 19 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00350714's enrollment target sits among peer trials

75 900th of 2000 higher than 1,081 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00350714, the US trial registry maintained by the National Library of Medicine. NCT00350714 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.