BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
NCT ID: NCT00736840
Last Updated: 2023-01-12
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
414 participants
INTERVENTIONAL
2008-08-31
2009-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Prediction Value of the BreathID 13C-Methacetin Breath Test for Hepatic Decompensation
NCT02084160
Assessing Portal Hypertension With Methacetin Breath Test
NCT02143778
13C-Methacetin Breath Test for the Prediction of Outcome in in ALI or ALF
NCT02786836
Use of Methacetin Breath Test to Predict Liver Failure in Patients With Cirrhosis
NCT01157845
Breath Test to Assess Hepatic Metabolic Reserve and to Predict Hepatic Decompensation in Cirrhotics
NCT00375011
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CLD (chronic liver disease)
Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver
c13 methacetin solution with breath analyzer
Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
c13 methacetin solution with breath analyzer
Carbon 13 methacetin 75mg dissolved in 150 ml is given to the subject and metabolism is measured by a breath analyzer after decomposed by the liver
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patient with severe congestive heart failure
* Patient with severe pulmonary hypertension
* Patient with uncontrolled diabetes mellitus
* Patient with previous surgical bypass surgery for morbid obesity
* Patient with extensive small bowel resection
* Patient currently receiving total parenteral nutrition
* Patient is a recipients of any organ transplant
* Patients that received any anti-viral treatment within the past year
* Women who are pregnant
* Patient allergic to acetaminophen (such as Tylenol or any other related medications)
* Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
* Patients unable to sign informed consent
* Patients that based on the opinion of the investigator should not be enrolled into this study
* Patients that are participating in other clinical trials evaluating experimental treatments or procedures
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Meridian Bioscience, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Stuart Gordon, MD
Role: PRINCIPAL_INVESTIGATOR
Henry Ford Health System
Adrian Rueben, MD
Role: PRINCIPAL_INVESTIGATOR
Medical University of South Carolina
Gadi Lalazar, MD
Role: PRINCIPAL_INVESTIGATOR
Hadassah Medical Organization
Arun Sanyal, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Fred Poordad, MD
Role: PRINCIPAL_INVESTIGATOR
Cedars Sinai Health System
K Rajender Reddy, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pennsylvania Health System
Zobair Younossi, MD
Role: PRINCIPAL_INVESTIGATOR
Inova Health Care Services
Arthur McCullough, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
John Vierling, MD
Role: PRINCIPAL_INVESTIGATOR
St. Luke's Episcopal Hospital, Baylor College of Medicine
Alexander Fich, MD
Role: PRINCIPAL_INVESTIGATOR
Soroka University Medical Center
Eli Zuckerman, MD
Role: PRINCIPAL_INVESTIGATOR
Carmel Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cedars Sinai Medical Center
Los Angeles, California, United States
Henry Ford Health Sytem
Detroit, Michigan, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
St Luke's Episcopal Hospital, Baylor College of Medicine
Houston, Texas, United States
Inova Helath System
Falls Church, Virginia, United States
Virginia Commonwealth University Medical Center
Richmond, Virginia, United States
Soroka Medical Center
Beersheba, , Israel
Carmel Medical Center
Haifa, , Israel
Hadassah Medical Center
Jerusalem, , Israel
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HIS-EX-408
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.