Clinical trial NCT00736840: BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis
Official title: Pivotal Study to Evaluate the Efficacy and Safety of the BreathID® System for Detection of Cirrhosis Using the ¹³C-methacetin Breath Test(MBT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Liver Disease
Keywords: Methacetin
Breath
Test
Cirrhosis
Lead sponsor: Meridian Bioscience, Inc.
Sponsor class: INDUSTRY
First posted: 2008-08-18
Enrollment: 414
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: Patients with chronic liver disease who have a recent biopsy will be offered a breath test. Correlation will be shown between histology and breath test in determining cirrhosis.

Eligibility criteria: Inclusion Criteria:

* Age \>18 with chronic liver disease

Exclusion Criteria:

* Patients that are taking hepatotoxin drug.
* 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

Primary outcomes:
measure: Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)
timeFrame: Study day 1 after a 1 hour test
Secondary outcomes:
measure: AUC of ROC (Area Under Receiver Operating Characteristic Curve)
timeFrame: At study day 1 after 1 hour test
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Detroit
country: United States
facility: Henry Ford Health Sytem
state: Michigan
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Philadelphia
country: United States
facility: University of Pennsylvania Health System
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: St Luke's Episcopal Hospital, Baylor College of Medicine
state: Texas
city: Falls Church
country: United States
facility: Inova Helath System
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University Medical Center
state: Virginia
city: Beer Sheba
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
Study officials:
affiliation: Henry Ford Health System
name: Stuart Gordon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Adrian Rueben, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Gadi Lalazar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Virginia Commonwealth University
name: Arun Sanyal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cedars Sinai Health System
name: Fred Poordad, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Pennsylvania Health System
name: K Rajender Reddy, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Inova Health Care Services
name: Zobair Younossi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Arthur McCullough, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Luke's Episcopal Hospital, Baylor College of Medicine
name: John Vierling, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Soroka University Medical Center
name: Alexander Fich, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Carmel Medical Center
name: Eli Zuckerman, MD
role: PRINCIPAL_INVESTIGATOR
References: