CClinicalTrials.gg
Sign In
CompletedNCT02143778Updated Dec 20, 2022Results posted

Assessing Portal Hypertension With Methacetin Breath Test

An interventional study of Methacetin Breath Test in Patients With Compensated Liver Cirrhosis, sponsored by Meridian Bioscience, Inc.. Completed at 8 sites in 4 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-20.

Sponsored by Meridian Bioscience, Inc. · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
246
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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,

Read the 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.

02

Conditions studied

  • Patients With Compensated Liver Cirrhosis

Keywords

  • MBT
  • CSPH
  • HVPG
03

In context

Liver Cirrhosis

1,642 studies on the registry are indexed under Liver Cirrhosis; 358 are open to participants now.

This study's enrollment of 246 is above the median of 72 across 995 interventional studies indexed under Liver Cirrhosis.

Browse Liver Cirrhosis studies →

Lead sponsor

Meridian Bioscience, Inc. is the lead sponsor of 27 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
246 participants (actual)

Study arms

  • 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

Interventions

  • DeviceMethacetin Breath Test

    13C labelled methacetin solution for breath test monitoring

06

What researchers measure

Primary outcomes

  1. CSPH (Clinically Significant Portal Hypertension)

    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.

    Time frame: 1 hour

Secondary outcomes

  1. Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)

    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.

    Time frame: 1 hour

07

Results

Posted Sep 19, 2019

Participant flow

Participant flow — Overall Study
MilestoneCompensated Cirrhotic Patients
Started246
Completed243
Not completed3
Withdrew: Withdrawal by subject2
Withdrew: Device malfunction1

Outcome measures

PrimaryCSPH (Clinically Significant Portal Hypertension)

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.

Time frame:
1 hour
Reported as:
Mean · percentage of agreement
CSPH (Clinically Significant Portal Hypertension)
percentage of agreementCompensated Cirrhotic Patients With CSPH
CSPH (Clinically Significant Portal Hypertension)81.82 (74.22 to 89.42)
SecondaryHepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)

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.

Time frame:
1 hour
Reported as:
Mean · percentage of agreement
Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)
percentage of agreementCompensated Cirrhotic Patients With SPH
Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)76.39 (66.58 to 86.20)

Adverse events

Collected over The Methacetin used in the breath test has a high extraction rate and is removed after less than 48 hours. Follow up was done for 48 hours after breath test. After 30 days another follow up phone call was made.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Compensated Cirrhotic Patients0/246 (0%)1/246 (0.4%)2/246 (0.8%)
Most frequent serious events
Most frequent serious events
EventCompensated Cirrhotic Patients
Severe DiarrheaGastrointestinal disorders1/246
Most frequent other events
Most frequent other events
EventCompensated Cirrhotic Patients
UTIInfections and infestations2/246

Baseline characteristics

Age, Continuous
Age, Continuous(years)Compensated Cirrhotic Patients
Mean60.6 ± 9.27
Sex: Female, Male
Sex: Female, Male(Participants)Compensated Cirrhotic Patients
Female93
Male153
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Compensated Cirrhotic Patients
Hispanic or Latino4
Not Hispanic or Latino242
Unknown or Not Reported0
Region of Enrollment
Region of Enrollment(participants)Compensated Cirrhotic Patients
United States39
France40
Switzerland9
Spain158
08

Study locations

8 sites
  • VA Connecticut HealthCare System
    New Haven, Connecticut 06516, United States
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • Virginia Commonwealth University
    Richmond, Virginia 23298, United States
  • Hôpital Beaujon
    Paris, France
  • Hopital Purpan
    Toulouse, France
  • (University of Barcelona) Hospital Clinic
    Barcelona, Spain
  • Hospital Universitario Ramón y Cajal
    Madrid, Spain
  • Inselspital
    Bern, 3010, Switzerland
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Nov 21, 2016

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 20, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02143778
Lead sponsor
Meridian Bioscience, Inc.
Responsible party
Sponsor
First posted
May 21, 2014
Start date
Nov 2014
Primary completion
Dec 2018
Completion
Jan 2019
Results posted
Sep 19, 2019
Last update
Dec 20, 2022

Study contacts

Juan Carlos Garcia Pagan, MD
principal investigator · University Hospital Barcelona

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Liver Cirrhosis→

Other studies from this sponsor

Meridian Bioscience, Inc.

Start the discussion