Assessing Portal Hypertension With Methacetin Breath Test

NCT02143778 | Completed Results

• 2 other identifiers: CSPH-EX-40142014-002037-59
• Study Type: interventional
• Target: 246
• Locations: 4 countries
• Sites: 8

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,

Conditions

Patients With Compensated Liver Cirrhosis

Keywords

MBT; CSPH; HVPG

Outcome Measures

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.

  1 hour

Secondary Outcomes (1)

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

  1 hour

Study Arms (1)

Compensated cirrhotic patients

EXPERIMENTAL

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

Methacetin Breath Test DEVICE

13C labelled methacetin solution for breath test monitoring

Compensated cirrhotic patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead

Study Sites (8)

VA Connecticut HealthCare System

New Haven, Connecticut, 06516, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Hôpital Beaujon

Paris, France

Location

Hopital Purpan

Toulouse, France

Location

(University of Barcelona) Hospital Clinic

Barcelona, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Inselspital

Bern, 3010, Switzerland

Location

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Exalenz Bisocience

avrahamh@exalenz.com

97289737500

Study Officials

• Juan Carlos Garcia Pagan, MD

  University Hospital Barcelona

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2014
• First Posted: May 21, 2014
• Study Start: November 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: January 1, 2019
• Last Updated: December 20, 2022
• Results First Posted: September 19, 2019

Record last verified: 2022-12

Locations

ES (2); US (3); CH (1); FR (2)