Assessing Portal Hypertension With Methacetin Breath Test

December 19, 2022 updated by: Meridian Bioscience, Inc.

Clinical Study of the BreathID® LF System to Train the Algorithm for the ¹³C-Methacetin Breath Test (MBT) in Assessment of Portal Hypertension in Patients With Compensated Liver Cirrhosis

This study will be used to train an algorithm using Methacetin breath test (MBT) measures and to select a cut-off to determine presence or absence of Clinically Significant Portal Hypertension (CSPH) as defined by Hepatic Venous Gradient Pressure (HVPG) ≥ 10mmHg,

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify CSPH and the agreement to the reference standard (HVPG) will be assessed in this study.

Study Type

Interventional

Enrollment (Actual)

246

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Hopital Beaujon
      • Toulouse, France
        • Hopital Purpan
  • Spain
      • Barcelona, Spain
        • (University of Barcelona) Hospital Clinic
      • Madrid, Spain
        • Hospital Universitario Ramón y Cajal
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06516
        • VA Connecticut Healthcare System
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult men or women (>18 years of age)
  • Known chronic liver disease with cirrhosis
  • Europe: Indicated to undergo HVPG testing
  • US: Consented for HVPG
  • For patients treated with beta blockers: They have to be on a stable dose for at least 6 weeks prior to any study related tasks
  • For patients who stopped their treatment with beta blockers: Their last dose should be at least 6 weeks prior to any study related tasks

Exclusion Criteria:

  • Decompensated cirrhosis as clinically defined by the presence of ascites, hepatic encephalopathy, variceal bleeding or hepatorenal syndrome
  • Renal failure (creatinine > 2.5 mg/dl)
  • Known acute renal tubular disease Known hypotension (Systolic Pressure <100mmHg)
  • Hypocoagulablity defined as PT >6 and INR >2.3.
  • Congestive heart failure (assessed clinically as NIHA >2)
  • Known pulmonary hypertension (right ventricular systolic pressure > 45 mm Hg)
  • Uncontrolled diabetes mellitus (HBA1C >9.5gr%)
  • Concurrent prednisone or immunosuppressive treatment, if therapy and/or response to treatment are not stable for at least 3 months.
  • Documented or suspected hepatocellular carcinoma
  • Gastric bypass surgery or extensive small bowel resection
  • Total parenteral nutrition
  • Any organ transplant recipient
  • Pregnant or breast feeding
  • Allergy to acetaminophen and/or other related medications
  • Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen)
  • Uncontrolled malabsorption or diarrhea
  • Documented non-cirrhotic PHT, partial / complete portal venous occlusion, hepatic venous occlusion, previous PHT surgery, or placement of a transjugular intrahepatic portosystemic shunt (TIPS)
  • Primary or secondary biliary cirrhosis, primary or secondary sclerosing cholangitis, hepatic sarcoidosis, or other cholestatic disorders
  • Subjects unable to perform the MBT within 7 days of HVPG procedure.
  • Subject should not have taken any of the following for at least 48 hours prior to the breath test: Acyclovir , allopurinol, amiodarone, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
  • Subject should not have taken amiodarone or statins within the last 30 days prior to the breath test or HVPG procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Compensated cirrhotic patients
A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis.
Device: Methacetin Breath Test
13C labelled methacetin solution for breath test monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CSPH (Clinically Significant Portal Hypertension)
Time Frame: 1 hour
Clinically significant portal hypertension is defined as Hepatic Venous Pressure Gradient (HVPG)>=10mmHg, whereby the portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify CSPH and the agreement to the reference standard (HVPG) will be assessed in this study.
1 hour

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)
Time Frame: 1 hour
Hepatic Venous Pressure Gradient greater than 12 (SPH) is an indicator of bleeding varices. whereby the portal pressure leaving the liver is measured by using a balloon catheter before and after a wedge. The difference of the pressure between the wedge and the free is the hepatic venous pressure gradient. Methacetin breath test is hypothesized to also identify SPH and the agreement to the reference standard (HVPG) will be assessed in this study.
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meridian Bioscience, Inc.

Investigators

  • Principal Investigator: Juan Carlos Garcia Pagan, MD, University Hospital Barcelona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2014

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

May 18, 2014

First Submitted That Met QC Criteria

May 18, 2014

First Posted (Estimate)

May 21, 2014

Study Record Updates

Last Update Posted (Estimate)

December 20, 2022

Last Update Submitted That Met QC Criteria

December 19, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CSPH-EX-4014
  • 2014-002037-59 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Patients With Compensated Liver Cirrhosis

Clinical Trials on Methacetin Breath Test

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe