BreathID 13C-Methacetin Breath Test for Detecting Cirrhosis

NCT00736840 | Completed Phase 3 Results DMC

• 1 other identifier: HIS-EX-408
• Study Type: interventional
• Target: 414
• Locations: 2 countries
• Sites: 11

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.

Conditions

Chronic Liver Disease

Keywords

Methacetin; Breath; Test; Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Number of Subjects With Likelihood of Cirrhosis Based on "Hepatic Impairment Score" (HIS)

  "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 result of cirrhosis detection as the gold standard.

  Study day 1 after a 1 hour test

Secondary Outcomes (1)

• AUC of ROC (Area Under Receiver Operating Characteristic Curve)

  At study day 1 after 1 hour test

Study Arms (1)

CLD (chronic liver disease)

OTHER

Chronic liver disease subjects with recent biopsy will be tested with a breath tests using a 13C enriched substrate metabolized by their liver

Device: c13 methacetin solution with breath analyzer

Interventions

c13 methacetin solution with breath analyzer DEVICE

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

CLD (chronic liver disease)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 with chronic liver disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (11)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Henry Ford Health Sytem

Detroit, Michigan, 48202, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29435, United States

Location

St Luke's Episcopal Hospital, Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Inova Helath System

Falls Church, Virginia, 22042, United States

Location

Virginia Commonwealth University Medical Center

Richmond, Virginia, 23298-0341, United States

Location

Soroka Medical Center

Beersheba, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Hadassah Medical Center

Jerusalem, 93000, Israel

Location

MeSH Terms

Conditions

Fibrosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Technical problems caused the termination of 2 subjects who did not complete breath test. Liver biopsy, 1 patient refused and others had signs of HCC thus disqualified.

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Exalenz Bioscience

avrahamh@exalenz.com

972-8-9737500

Study Officials

• Stuart Gordon, MD

  Henry Ford Health System

  PRINCIPAL INVESTIGATOR

• Adrian Rueben, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Gadi Lalazar, MD

  Hadassah Medical Organization

  PRINCIPAL INVESTIGATOR

• Arun Sanyal, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

• Fred Poordad, MD

  Cedars Sinai Health System

  PRINCIPAL INVESTIGATOR

• K Rajender Reddy, MD

  University of Pennsylvania Health System

  PRINCIPAL INVESTIGATOR

• Zobair Younossi, MD

  Inova Health Care Services

  PRINCIPAL INVESTIGATOR

• Arthur McCullough, MD

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

• John Vierling, MD

  St. Luke's Episcopal Hospital, Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

• Alexander Fich, MD

  Soroka University Medical Center

  PRINCIPAL INVESTIGATOR

• Eli Zuckerman, MD

  Carmel Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2008
• First Posted: August 18, 2008
• Study Start: August 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: January 12, 2023
• Results First Posted: March 16, 2012

Record last verified: 2022-12

Locations

US (8); IL (3)