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NCT00736840 · ClinicalTrials.gov registry record · Phase 3

BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

A Phase 3 study of Chronic Liver Disease, sponsored by Meridian Bioscience.

Completed
Registry status
Phase 3
Development phase
414
Enrollment target
11
Study locations

NCT00736840 is a Phase 3 study of Chronic Liver Disease that has completed, run by Meridian Bioscience. The registered enrollment target is 414 participants, above the 286-participant average among 5 other Chronic Liver Disease trials with a reported enrollment target (45% higher). The trial reports 11 study locations across 8 states.

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The verdict

NCT00736840, a Phase 3 study of Chronic Liver Disease, has completed, sponsored by Meridian Bioscience.

COMPLETED
Registry status
Phase 3
Development phase
414 participants
Enrollment target
11
Study locations

Study Summary

This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

Conditions Studied

Interventions

  • DEVICE c13 methacetin solution with breath analyzer

Study Locations (11)

Other

  • Soroka Medical Center - Beersheba
  • Carmel Medical Center - Haifa
  • Hadassah Medical Center - Jerusalem

Virginia

  • Inova Helath System - Falls Church
  • Virginia Commonwealth University Medical Center - Richmond

California

  • Cedars Sinai Medical Center - Los Angeles

Michigan

  • Henry Ford Health Sytem - Detroit

Ohio

  • Cleveland Clinic - Cleveland

Pennsylvania

  • University of Pennsylvania Health System - Philadelphia

South Carolina

  • Medical University of South Carolina - Charleston

Texas

  • St Luke's Episcopal Hospital, Baylor College of Medicine - Houston

Trial Details

FieldValue
Enrollment Target 414 participants
Start Date 2008-08
Est. Completion 2009-09
Phase Phase 3

Sponsor

Meridian Bioscience

19 total trials

What the Registry Record Tells You About NCT00736840

The ClinicalTrials.gov registry entry for NCT00736840 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 414 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 286-participant average among 5 other Chronic Liver Disease trials with a reported enrollment target (45% higher). The listed sponsor is Meridian Bioscience, which has 19 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Chronic Liver Disease appearing as the primary indexed condition, and to 1 intervention - of which c13 methacetin solution with breath analyzer is the first listed.

NCT00736840 reports 11 study locations spanning 8 distinct geographic areas - top geographies include Other, Virginia, California.

Frequently Asked Questions

What is clinical trial NCT00736840 about?

NCT00736840 is a clinical study titled "BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis". This trial is a pivotal trial to validate the use of a 13 C labeled substrate called methacetin and the BreathID automatic breath testing system, for determination of cirrhosis in patients with chronic liver disease.

What is the current status of trial NCT00736840?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 414 participants. The study started on 2008-08. Estimated completion is 2009-09.

What conditions does trial NCT00736840 study?

This clinical trial studies the following conditions: Chronic Liver Disease.

What interventions are being tested in trial NCT00736840?

The interventions under investigation include: c13 methacetin solution with breath analyzer (DEVICE).

Who is sponsoring clinical trial NCT00736840?

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

Where is trial NCT00736840 being conducted?

This trial has 11 study locations across California, Michigan, Ohio, Pennsylvania, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.