Decompensated CirrhosisNCT03462576
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17
A study testing Methacetin Breath Test and Emricasan in people with Decompensated Cirrhosis, run by Meridian Bioscience, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- Methacetin Breath Test and Emricasan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 199 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2017to 15 Jul 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
- Male or female subjects 18 years or older, able to provide written informed consent and able to understand and willing to comply with the requirements of the study.
- Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
- At least one of the following: a) history of variceal hemorrhage (more than 3 months prior to day 1) documented on endoscopy and requiring blood transfusion, b) history of at least moderate ascites (on physical exam or imaging) currently treated with diuretics.
- MELD score ≥12 and ≤20 during screening
- Albumin ≥2.5 g/dL during screening
- Serum creatinine ≤1.5 mg/dL during screening
Who cannot join
- Evidence of severe decompensation
- Non-cirrhotic portal hypertension
- Child-Pugh score ≥10
- Current use of anticoagulants that affect prothrombin time or international normalized ratio
- ALT >3 times upper limit of normal (ULN) or AST >5 times ULN during screening
- Initiation or discontinuation of non-selective beta blockers within 1 month of screening
Show all 21Show fewer
- Transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure within 1 year of screening or previously requiring revision
- Alpha-fetoprotein >50 ng/mL in the last year
- History of hepatocellular carcinoma (HCC) or evidence of HCC
- History of malignancies other than HCC, unless successfully treated with curative intent and believed to be cured
- Prior liver transplant
- Uncontrolled diabetes mellitus (HbA1c >9%)
- Change in diabetes medications or vitamin E within 3 months of screening
- Restrictive bariatric surgery or bariatric device within 1 year of screening or prior malabsorptive bariatric surgery
- Symptoms of biliary colic unless resolved following cholecystectomy
- History of significant alcohol consumption within the past 5 years
- Current use of medications that are considered inhibitors of organic anion transporting polypeptide OATP1B1 and OATP1B3 transporters
- Prolongation of screening (pre-treatment) QTcF interval of >500 msecs, or history or presence of clinically concerning cardiac arrhythmias
- Significant systemic or major illness other than liver disease
- Human immunodeficiency virus infection
- Use of alcohol, controlled substances (including inhaled or injected drugs), or non-prescribed use of prescription drugs within 1 year of screening to the point of interfering with the subject's ability to comply with study procedures and study drug administration in the investigator's judgement
Trial locations and contacts
1 site in 1 country.
United States1 site
Florida Digestive Health Specialists Research Institute
Lakewood Rch, Florida, 34211
About this study
Official title: Companion Protocol for the ¹³C-Methacetin Breath Test Using the BreathID® MCS System for Conatus Phase 2 Study of Emricasan, an Oral Caspase Inhibitor, Under Protocol IDN-6556-17
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.
Read the detailed description
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) ].
- Conditions
- Decompensated Cirrhosis
- Being tested
- Methacetin Breath Test, Emricasan, Placebo oral capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methacetin Breath TestCombination product
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.
EmricasanDrug
Investigational drug for NASH treatment in Main Conatus protocol
Placebo oral capsuleDrug
Placebo versus emricasan in Conatus NASH treatment trial
| Study group | Role | What they receive |
|---|---|---|
| Emricasan 25mg | Experimental | 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. Receives: Combination Product: Methacetin Breath Test; Drug: Emricasan |
| Emricasan 5mg | Experimental | 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. Receives: Combination Product: Methacetin Breath Test; Drug: Emricasan |
| Placebo | Placebo comparator | 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. Receives: Combination Product: Methacetin Breath Test; Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 hour for MBT for assessment of this diagnostic outcome assessed during screening
Secondary outcomes (1)
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.
Measured: 1 hour for MBT for assessment of this diagnostic outcome assessed during screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2018
- Study start28 Jun 2017
- Primary completion15 Jul 2019
- Study completion15 Jul 2019
Why it stopped: Sponsor of Trial decision
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 Decompensated 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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. All subjects will continue treatment until the last subject in the study reaches 48 weeks in the study. At least 30% of subjects randomized should have baseline MELD score ≥15 and ≤20. For each subject, the study will consist of: * Screening period of up to 4 weeks * Randomized, double-blind treatment period of at least 48 weeks * A follow-up visit 2 weeks after completion of study drug treatment The duration of each subject's participation will be at least 54 weeks for those completing the entire study.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meridian Bioscience, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Conatus Pharmaceuticals Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03462576
- Sponsor's protocol ID
- CON-EX-0217
- Status last verified
- Dec 2022
- First submitted
- 6 Mar 2018
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- 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
- Companion Protocol for the ¹³C-Methacetin Breath Test Using the BreathID® MCS System for Conatus Phase 2 Study of Emricasan, an Oral Caspase Inhibitor, Under Protocol IDN-6556-17
- ClinicalTrials.gov ID
- NCT03462576
- Acronym / sponsor ID
- CON-EX-0217
- Conditions
- Decompensated Cirrhosis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor of Trial decision
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Meridian Bioscience, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Conatus Pharmaceuticals Inc.
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 15 Jul 2019 (actual)
- Study completion
- 15 Jul 2019 (actual)
- First posted
- 12 Mar 2018 (actual)
- Results
- Posted 16 Dec 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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) ].
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- 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. All subjects will continue treatment until the last subject in the study reaches 48 weeks in the study. At least 30% of subjects randomized should have baseline MELD score ≥15 and ≤20. For each subject, the study will consist of: * Screening period of up to 4 weeks * Randomized, double-blind treatment period of at least 48 weeks * A follow-up visit 2 weeks after completion of study drug treatment The duration of each subject's participation will be at least 54 weeks for those completing the entire study.
| Arm | Type | Receives |
|---|---|---|
| Emricasan 25mg | Experimental | Combination Product: Methacetin Breath Test, Drug: EmricasanThe 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. |
| Emricasan 5mg | Experimental | Combination Product: Methacetin Breath Test, Drug: EmricasanThe 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. |
| Placebo | Placebo comparator | Combination Product: Methacetin Breath Test, Drug: Placebo oral capsuleThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female subjects 18 years or older, able to provide written informed consent and able to understand and willing to comply with the requirements of the study.
- Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
- At least one of the following: a) history of variceal hemorrhage (more than 3 months prior to day 1) documented on endoscopy and requiring blood transfusion, b) history of at least moderate ascites (on physical exam or imaging) currently treated with diuretics.
- MELD score ≥12 and ≤20 during screening
- Albumin ≥2.5 g/dL during screening
Key exclusion criteria (21 listed)
- Evidence of severe decompensation
- Non-cirrhotic portal hypertension
- Child-Pugh score ≥10
- Current use of anticoagulants that affect prothrombin time or international normalized ratio
- ALT >3 times upper limit of normal (ULN) or AST >5 times ULN during screening
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 TestA 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. | Combination product | Emricasan 25mg, Emricasan 5mg, Placebo |
| EmricasanInvestigational drug for NASH treatment in Main Conatus protocol | Drug | Emricasan 25mg, Emricasan 5mg |
| Placebo oral capsulePlacebo versus emricasan in Conatus NASH treatment trial | Drug | Placebo |
Primary outcome
Number of Subjects Experiencing a High Risk Event Based on a 5.5%/Hour Cut-off
Time frame: 1 hour for MBT for assessment of this diagnostic outcome assessed during screening
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.
1 secondary outcome
Number of Subjects Experiencing a High Risk Event Based on a 7.5 %/Hour Cut-off
Time frame: 1 hour for MBT for assessment of this diagnostic outcome assessed during screening
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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methacetin Breath Test and Emricasan in people with Decompensated Cirrhosis, run by Meridian Bioscience, Inc. at 1 site in United States.
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: stopped early, 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 1 site in United States. 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. Some participants in this study may receive a placebo. 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 16 Dec 2020). 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?
Number of Subjects Experiencing a High Risk Event Based on a 5.5%/Hour Cut-off (time frame: 1 hour for MBT for assessment of this diagnostic outcome assessed during screening). 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.