An interventional study of Methacetin Breath Test and Emricasan in Decompensated Cirrhosis, sponsored by Meridian Bioscience, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Meridian Bioscience, Inc. (part of SD Biosensor) · Interventional and Diagnostic
This study is a companion protocol that will use the data generated by Conatus' study of emricasan under protocol IDN-6556-17.The IDN-6556-17 study is a Phase 2, multicenter, double-blind, placebo-controlled trial of Emricasan in subjects with decompensated non-alcoholic steatohepatitis (NASH) cirrhosis.
The protocol is intended to validate the ability of the MBT to predict deterioration by 48 weeks for all subjects, and at later time points for those followed longer, for subjects with decompensated NASH cirrhosis in the placebo treatment arm of Conatus' study IDN-6556-17.
As one of the Conatus' study secondary objectives, this companion protocol is designed to assess improvement in liver metabolic function as measured by Methacetin Breath Test (MBT) [ Time Frame: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks) ].
Meridian Bioscience, Inc. is the lead sponsor of 27 studies on the registry; none are open to participants now.
First submitted before Meridian Bioscience, Inc. became part of SD Biosensor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study treatment duration will be at least 48 weeks with study visits every 4 weeks up to Week 48 and every 8 weeks after Week 48.
Combination Product: Methacetin Breath Test · Drug: Emricasan
The study treatment duration will be at least 48 weeks with study visits every 4 weeks up to Week 48 and every 8 weeks after Week 48.
Combination Product: Methacetin Breath Test · Drug: Emricasan
The study treatment duration will be at least 48 weeks with study visits every 4 weeks up to Week 48 and every 8 weeks after Week 48.
Combination Product: Methacetin Breath Test · Drug: Placebo oral capsule
A breath analyzer will be used to measure changes in carbon 12 to carbon13 ratio as a result of metabolism of the Methacetin substrate before and after treatment.
Investigational drug for NASH treatment in Main Conatus protocol
Placebo versus emricasan in Conatus NASH treatment trial
Number of Subjects Experiencing a High Risk Event Based on a 5.5%/Hour Cut-off
Binary diagnosis of subjects that are at high risk to develop a deterioration event as determined by the Methacetin Breath Test (MBT) derived from an algorithm developed under other Exalenz clinical studies using a pre-designed cutoff of Percentage Dose Recovery (PDR) peak of \< 5.5%/hour. The data was collected and analyzed agnostic to the intervention.
Time frame: 1 hour for MBT for assessment of this diagnostic outcome assessed during screening
Number of Subjects Experiencing a High Risk Event Based on a 7.5 %/Hour Cut-off
Binary diagnosis of subjects that are at high risk to develop a deterioration event as determined by the Methacetin Breath Test (MBT) derived from an algorithm developed under other Exalenz clinical studies using a pre-designed cutoff of Percentage Dose Recovery (PDR) peak of \< 7.5%/hour.The data was collected and analyzed agnostic to the intervention.
Time frame: 1 hour for MBT for assessment of this diagnostic outcome assessed during screening
| Milestone | Patients With Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in Placebo Arm |
|---|---|---|---|
| Started | 46 | 48 | 45 |
| Completed | 41 | 37 | 37 |
| Not completed | 5 | 11 | 8 |
| Withdrew: Protocol violation | 5 | 11 | 7 |
| Withdrew: Device malfunction | 0 | 0 | 1 |
Binary diagnosis of subjects that are at high risk to develop a deterioration event as determined by the Methacetin Breath Test (MBT) derived from an algorithm developed under other Exalenz clinical studies using a pre-designed cutoff of Percentage Dose Recovery (PDR) peak of \< 5.5%/hour. The data was collected and analyzed agnostic to the intervention.
| Participants | Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in Placebo Arm |
|---|---|---|---|
| Events in subjects below cut-off | 3 | 4 | 6 |
| No event recorded in subjects below cut-off | 1 | 2 | 5 |
| Events in subjects above cut-off | 15 | 14 | 11 |
| No event recorded in subjects above cut-off | 27 | 28 | 22 |
Binary diagnosis of subjects that are at high risk to develop a deterioration event as determined by the Methacetin Breath Test (MBT) derived from an algorithm developed under other Exalenz clinical studies using a pre-designed cutoff of Percentage Dose Recovery (PDR) peak of \< 7.5%/hour.The data was collected and analyzed agnostic to the intervention.
| Participants | Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in Placebo Arm |
|---|---|---|---|
| Events in subjects below cut-off | 4 | 8 | 9 |
| No event recorded in subjects below cut-off | 4 | 4 | 6 |
| Events in subjects above cut-off | 14 | 10 | 8 |
| No event recorded in subjects above cut-off | 24 | 26 | 21 |
Collected over Adverse event data was collected for a period of 48 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm | 0/46 (0%) | 0/46 (0%) | 1/46 (2.2%) |
| Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm | 0/48 (0%) | 0/48 (0%) | 1/48 (2.1%) |
| Number of Subjects Experiencing a High Risk Event in Placebo Arm | 0/45 (0%) | 0/45 (0%) | 0/45 (0%) |
| Event | Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in Placebo Arm |
|---|---|---|---|
| Productive coughRespiratory, thoracic and mediastinal disorders | 1/46 | 0/48 | 0/45 |
| URIRespiratory, thoracic and mediastinal disorders | 0/46 | 1/48 | 0/45 |
| Age, Continuous(years) | Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in Placebo Arm | Total |
|---|---|---|---|---|
| Mean | 59.674 ± 9.307 | 60.875 ± 8.668 | 62.864 ± 7.135 | 61.1 ± 8.48 |
| Sex: Female, Male(Participants) | Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in Placebo Arm | Total |
|---|---|---|---|---|
| Female | 26 | 19 | 27 | 72 |
| Male | 20 | 29 | 17 | 66 |
| Race (NIH/OMB)(Participants) | Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in Placebo Arm | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 1 | 1 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 1 | 3 |
| White | 43 | 43 | 41 | 127 |
| More than one race | 1 | 2 | 1 | 4 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Region of Enrollment(Participants) | Number of Subjects Experiencing a High Risk Event in 25 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in 5 mg Treatment Arm | Number of Subjects Experiencing a High Risk Event in Placebo Arm | Total |
|---|---|---|---|---|
| United States | 46 | 48 | 44 | 138 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Studies of the drug tested here: Emricasan