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Assessing Portal Hypertension With Methacetin Breath Test

Primary Purpose

Patients With Compensated Liver Cirrhosis

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Methacetin Breath Test
Sponsored by
Meridian Bioscience, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Patients With Compensated Liver Cirrhosis focused on measuring MBT, CSPH, HVPG

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • VA Connecticut HealthCare System
  • Duke University Medical Center
  • Virginia Commonwealth University
  • Hôpital Beaujon
  • Hopital Purpan
  • (University of Barcelona) Hospital Clinic
  • Hospital Universitario Ramón y Cajal
  • Inselspital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Compensated cirrhotic patients

Arm Description

A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 18, 2014
Last Updated
December 19, 2022
Sponsor
Meridian Bioscience, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02143778
Brief Title
Assessing Portal Hypertension With Methacetin Breath Test
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
January 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Meridian Bioscience, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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,
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Compensated Liver Cirrhosis
Keywords
MBT, CSPH, HVPG

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
246 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Compensated cirrhotic patients
Arm Type
Experimental
Arm Description
A methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis.
Intervention Type
Device
Intervention Name(s)
Methacetin Breath Test
Intervention Description
13C labelled methacetin solution for breath test monitoring
Primary Outcome Measure Information:
Title
CSPH (Clinically Significant Portal Hypertension)
Description
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 Outcome Measure Information:
Title
Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Garcia Pagan, MD
Organizational Affiliation
University Hospital Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut HealthCare System
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Hôpital Beaujon
City
Paris
Country
France
Facility Name
Hopital Purpan
City
Toulouse
Country
France
Facility Name
(University of Barcelona) Hospital Clinic
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

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Assessing Portal Hypertension With Methacetin Breath Test

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