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Assessing Portal Hypertension With Methacetin Breath Test

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ClinicalTrials.gov Identifier: NCT02143778
Recruitment Status : Recruiting
First Posted : May 21, 2014
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Exalenz Bioscience LTD.

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

Condition or disease Intervention/treatment Phase
Patients With Compensated Liver Cirrhosis Device: Methacetin Breath Test Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 2014
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis

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




Primary Outcome Measures :
  1. CSPH [ Time Frame: 1 hour ]
    Clinically significant portal hypertension , defined as Hepatic Venous Pressure Gradient (HVPG)>=10mmHg


Secondary Outcome Measures :
  1. HVPG>=12 [ Time Frame: 1 hour ]
    Hepatic Venous Pressure Gradient greater than 12 is an indicator of bleeding varices



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02143778


Contacts
Contact: Avraham Hershkowitz, MSc +972-8-9737513 avrahamh@exalenz.com

Locations
United States, Connecticut
VA Connecticut HealthCare System Completed
New Haven, Connecticut, United States, 06516
United States, North Carolina
Duke University Medical Center Completed
Durham, North Carolina, United States, 27710
United States, Virginia
Virginia Commonwealth University Completed
Richmond, Virginia, United States, 23298
France
Hôpital Beaujon Completed
Paris, France
Hopital Purpan Completed
Toulouse, France
Spain
(University of Barcelona) Hospital Clinic Recruiting
Barcelona, Spain
Contact: Lara Orts Salvador    34 93 2275400 ext 2473    LORTS@clinic.cat   
Principal Investigator: Juan Carlos Garcia Pagan, MD         
Hospital Universitario Ramón y Cajal Recruiting
Madrid, Spain
Contact: Javier M Martinez Gonzalez    +34 913368381    martinez.gonzalez.javier@gmail.com   
Principal Investigator: Agustin Albillos, M.D.         
Switzerland
Inselspital Completed
Bern, Switzerland, 3010
Sponsors and Collaborators
Exalenz Bioscience LTD.
Investigators
Principal Investigator: Juan Carlos Garcia Pagan, MD University Hospital Barcelona

Responsible Party: Exalenz Bioscience LTD.
ClinicalTrials.gov Identifier: NCT02143778     History of Changes
Other Study ID Numbers: CSPH-EX-4014
2014-002037-59 ( EudraCT Number )
First Posted: May 21, 2014    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Keywords provided by Exalenz Bioscience LTD.:
MBT
CSPH
HVPG

Additional relevant MeSH terms:
Hypertension
Fibrosis
Liver Cirrhosis
Hypertension, Portal
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Liver Diseases
Digestive System Diseases