Patients With Compensated Liver CirrhosisNCT02143778
Assessing Portal Hypertension With Methacetin Breath Test
A study testing Methacetin Breath Test in people with Patients With Compensated Liver Cirrhosis, run by Meridian Bioscience, Inc. at 8 sites in 4 countries.
Trial 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, Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patients With Compensated Liver Cirrhosis
- What is being tested?
- Methacetin Breath Test
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 8 sitesin 4 countries
- Study dates
- Nov 2014to Jan 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 21Show fewer
- 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
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United States3 sites
Duke University Medical Center
Durham, North Carolina, 27710
VA Connecticut HealthCare System
New Haven, Connecticut, 06516
Virginia Commonwealth University
Richmond, Virginia, 23298
Spain2 sites
(University of Barcelona) Hospital Clinic
Barcelona
Hospital Universitario Ramón y Cajal
Madrid
About this study
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
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,
Read the 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.
- Being tested
- Methacetin Breath Test
- Keywords
- MBT, CSPH, HVPG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacetin Breath TestDevice
13C labelled methacetin solution for breath test monitoring
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Methacetin Breath Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour
Secondary outcomes (1)
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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2014 (estimated)
- Study startNov 2014
- Primary completionDec 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Patients With Compensated Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan Carlos Garcia Pagan, MD, Principal investigator, University Hospital Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02143778
- Sponsor's protocol ID
- CSPH-EX-4014
- Other IDs
- 2014-002037-59, 2014
- Status last verified
- Dec 2022
- First submitted
- 18 May 2014
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02143778
- Acronym / sponsor ID
- CSPH-EX-4014
- Keywords
- MBT, CSPH, HVPG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 21 May 2014 (estimated)
- Results
- Posted 19 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Compensated cirrhotic patients | Experimental | Device: Methacetin Breath TestA methacetin breath test will be performed on patients who are undergoing the HVPG procedure due to their clinical indication of compensated cirrhosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (21 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Methacetin Breath Test13C labelled methacetin solution for breath test monitoring | Device | Compensated cirrhotic patients |
Primary outcome
CSPH (Clinically Significant Portal Hypertension)
Time frame: 1 hour
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 secondary outcome
Hepatic Venous Pressure Gradient (HVPG)>=12; Severe Portal Hypertension (SPH)
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Patients With Compensated Liver Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
Not yet recruiting
Body-weight Reduction Effect on Portal Hypertension in Compensated Cirrhosis
Cirrhosis, Portal Hypertension
RecruitingPhase 1
Direct Oral Anticoagulants (Rivaroxaban and Apixaban) in Patients With Liver Cirrhosis
Liver Cirrhosis
Active, not recruitingPhase 3
A Phase 3 Study to Evaluate the Effect of Resmetirom on Clinical Outcomes in Patients With Well-compensated NASH Cirrhosis (MAESTRO-NASH-OUTCOMES)
NASH, Cirrhosis, Liver
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juan Carlos Garcia Pagan, MD principal investigator
University Hospital Barcelona
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methacetin Breath Test in people with Patients With Compensated Liver Cirrhosis, run by Meridian Bioscience, Inc. at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, France, Spain, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CSPH (Clinically Significant Portal Hypertension) (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.