N/A
N=246
Assessing Portal Hypertension With Methacetin Breath Test
Patients With Compensated Liver Cirrhosis
Bottom Line
View on ClinicalTrials.gov: NCT02143778 ↗Enrolled (actual)
246
Serious AEs
0.4%
Results posted
Sep 2019
Primary outcome: Primary: CSPH (Clinically Significant Portal Hypertension) — 81.82 percentage of agreement
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Methacetin Breath Test (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Meridian Bioscience, Inc.
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY CSPH (Clinically Significant Portal Hypertension) |
81.82 | — |
| SECONDARY Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH) |
76.39 | — |
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,
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 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
Data sourced from ClinicalTrials.gov (NCT02143778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.