BreathID Multi-center HCV Liver Breath Test Study

Summary

The goal of this study is to validate the BreathID 13C-methacetin breath test (MBT) as a non-invasive simple-to-use metabolic test, which could be utilized to detect severe liver fibrosis (\>2 in METAVIR) in patients with chronic HCV liver disease.The test is a breath-test using a free-standing device (BreathID®) that measures metabolization of a 13C-labeled substrate (13C-methacetin) in real time.

Conditions

• Hepatitis C

Interventions

OTHER

MBT and BreathID

75 mg methacetin (c13 labelled) dissolved in 150 cc water ingested and breath collected before and after ingestion.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai

  collaborator OTHER

• Baylor College of Medicine

  collaborator OTHER

• Virginia Commonwealth University

  collaborator OTHER

• Hadassah Medical Organization

  collaborator OTHER

• US Department of Veterans Affairs

  collaborator FED

• Meridian Bioscience, Inc.

  lead INDUSTRY

Principal Investigators

• Doug Dieterich, MD · Icahn School of Medicine at Mount Sinai

• John M Vierling, MD · Baylor College of Medicine

• Mitchell Shiffman, MD · Virginia Commonwealth University

• Maya Margalit, MD · Hadassah Medical Organization

• Douglas M. Heuman, M.D. · U.S. Dept. of Veteran Affairs, Hunter Holmes McGuire Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2006-07-31

Primary Completion

2007-02-28

Completion

2007-02-28

Countries

• United States
• Israel

Study Locations