Assessing Portal Hypertension With Methacetin Breath Test

Completed · Not applicable

Conditions studied: Patients With Compensated Liver Cirrhosis

In brief

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,

Key facts

Study ID

NCT02143778

Run by

Meridian Bioscience, Inc.

People needed

246

Starts

2014-11-01

Expected to finish

2019-01-01

Last updated by the study team

2022-12-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• VA Connecticut HealthCare System — New Haven, Connecticut, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Virginia Commonwealth University — Richmond, Virginia, 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, Switzerland

Full record on ClinicalTrials.gov

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