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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: Completed Phase 3 study of Chronic Liver Disease, sponsored by Meridian Bioscience.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
"Hepatic Impairment Score" (HIS) is a score based on breath test parameters and demographic parameters of the subject being tested. A HIS value greater than 0.14 would mean that the subject is likely to be cirrhotic (based on biopsy result as the gold standard). The HIS is a probability score,i.e. ranges from 0 to 1, where 0 would mean the lowest probability of having liver cirrhosis and 1 would be the highest probability of having liver cirrhosis. This would be compared to the actual biopsy res
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
| Field | Value |
|---|---|
| Enrollment Target | 414 participants |
| Start Date | 2008-08 |
| Est. Completion | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00736840 record still lists
NCT00736840 is an interventional study that assigns participants to a tested intervention. The registered 414 participants enrollment target is mid-sized for trials with a published cap, above the 286-participant average among 5 other Chronic Liver Disease trials with a reported enrollment target (45% higher).
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 lists 11 locations in 8 states (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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