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Decompensated CirrhosisPhase 2ENCORE-LFNCT03205345

Emricasan, a Caspase Inhibitor, for Treatment of Subjects With Decompensated NASH Cirrhosis

A Phase 2 study testing Emricasan (25 mg) and Emricasan (5 mg) in people with Decompensated Cirrhosis, run by Conatus Pharmaceuticals Inc. at 76 sites in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new decompensation events, and MELD score progression are events) in subjects with decompensated… 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?
Emricasan (25 mg) and Emricasan (5 mg)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
210 participants
Where
76 sitesUnited States
Study dates
28 Jun 2017to Aug 2019
Phase
Phase 2
Are there results?
None posted in the registry

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

76 sites in 1 country.

76 sites in 1 country

United States76 sites

  • Aquiant Research

    Albany, Indiana, 47150

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Piedmont Transplant Institute

    Atlanta, Georgia, 30309

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Mercy Medical Center

    Baltimore, Maryland, 21202

  • Delta Research Partners

    Bastrop, Louisiana, 71220

  • Walter Reed National Military Medical Center (WRNMMC)

    Bethesda, Maryland, 20889

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Digestive Disease Associates, PA

    Catonsville, Maryland, 21228

  • The Institute for Liver Health

    Chandler, Arizona, 85224

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Carolinas Healthcare System, Center for Liver Disease

    Charlotte, North Carolina, 28204

  • University of Virginia

    Charlottesville, Virginia, 22908

  • ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Northwestern University

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • UC Health/ UCPC LLC

    Cincinnati, Ohio, 45267

  • Peak Enterology Associates

    Colorado Springs, Colorado, 80907

  • Methodist Health System Clinical Research Institute

    Dallas, Texas, 75203

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Baylor Scott & White Research Institute

    Fort Worth, Texas, 76104

  • University of California, San Francisco-Fresno

    Fresno, California, 93701

  • UF Hepatology Research at CTRB

    Gainesville, Florida, 32610

  • GHS Gastroenterology and Liver Center

    Greenville, South Carolina, 29605

  • Baylor College of Medicine - Advanced Liver Therapies

    Houston, Texas, 77030

  • Liver Associates of Texas, P.A.

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics/ Internal Medicine

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center, Division of Digestive Diseases

    Jackson, Mississippi, 39216

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Emeritas Research Group LLC

    Leesburg, Virginia, 20176

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA Pfleger Liver Institute

    Los Angeles, California, 90095

  • Northwell Health Inc., Sandra Atlas Bass Center for Liver Diseases.

    Manhasset, New York, 11030

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Schiff Center for Liver Disease/University of Miami

    Miami, Florida, 33136

  • Diabetes & Endocrinology Consultants, PC

    Morehead City, North Carolina, 28557

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • NYU Medical Center

    New York, New York, 10016

  • Weill Cornell Medical College

    New York, New York, 10021

  • Columbia University Medical Center - Center for Liver Disease and Transplantation

    New York, New York, 10032

  • Rutgers New Jersey Medical School

    Newark, New Jersey, 07103

  • Banner University Medical Center - Phoenix Transplant Institute

    Newport News, Virginia, 23602

  • Florida Hospital Transplant Institute

    Orlando, Florida, 32804

  • IMIC Inc.

    Palmetto Bay, Florida, 33157

  • California Liver Research Institute

    Pasadena, California, 91105

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • St. Joseph's Hospital & Medical Center

    Phoenix, Arizona, 85013

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

  • Stanford University

    Redwood City, California, 94063

  • Inland Empire Liver Foundation

    Rialto, California, 92377

  • Bon Secours Liver Institute of Virginia

    Richmond, Virginia, 23226

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55901

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • UC Davis GI/Hepatology Clinical Trials Unit

    Sacramento, California, 95817

  • University of Utah

    Salt Lake City, Utah, 84132

  • American Research Corporation at the Texas Liver Institue

    San Antonio, Texas, 78215

  • Methodist Specialty & Transplant Hospital

    San Antonio, Texas, 78229

  • San Antonio Military Medical Center

    San Antonio, Texas, 78234

  • Scripps Clinic - Torrey Pines

    San Diego, California, 92037

  • California Pacific Medical Center

    San Francisco, California, 94115

  • University of California San Francisco

    San Francisco, California, 94143

  • Swedish Organ Transplant and Liver Center

    Seattle, Washington, 98104

  • University of Washington Harborview Medical Center

    Seattle, Washington, 98104

  • University of Washington

    Seattle, Washington, 98195

  • Tampa General Hospital

    Tampa, Florida, 33606

  • University of Arizona Liver Research Institute

    Tucson, Arizona, 85747

  • Options Health Research, LLC

    Tulsa, Oklahoma, 74104

  • West Haven VA Medical Center

    West Haven, Connecticut, 06516

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Emricasan, an Oral Caspase Inhibitor, in Subjects With Decompensated Non-Alcoholic Steatohepatitis (NASH) Cirrhosis

This is a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of emricasan in improving event-free survival based on a composite clinical endpoint (where all-cause mortality, new decompensation events, and MELD score progression are events) in subjects with decompensated NASH cirrhosis.

Read the detailed 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.

Being tested
Emricasan (25 mg), Emricasan (5 mg), Placebo
Keywords
Cirrhosis, NASH Cirrhosis, Decompensated NASH cirrhosis, Cirrhosis, Liver, Non-Alcoholic Fatty Liver Disease
Medical subject headings
Fibrosis, Liver Cirrhosis, Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Emricasan (25 mg)Drug

    Also called IDN-6556

    25 mg emricasan

  • Emricasan (5 mg)Drug

    Also called IDN-6556

    5 mg emricasan

  • PlaceboDrug

    Also called Matching placebo

    Matching Placebo

Study groups in NCT03205345
Study groupRoleWhat they receive
Emricasan (25 mg)Active comparatorEmricasan 25 mg
Receives: Drug: Emricasan (25 mg)
Emricasan (5 mg)Active comparatorEmricasan 5mg
Receives: Drug: Emricasan (5 mg)
PlaceboPlacebo comparatorMatching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Comparison of the effect of emricasan on improving event-free survival relative to placebo, based on a composite clinical endpoint

    Measured: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)

Secondary outcomes (8)

  1. Improvement in MELD score

    The effect of emricasan on improving MELD score relative to placebo

    Measured: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)

  2. Improvement in Child-Pugh scores

    The effect of emricasan on improving the Child-Pugh score relative to placebo

    Measured: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)

  3. Reduction of the proportion of subjects with MELD score progression

    The effect of emricasan on reducing the proportion of patients with MELD score progression (≥4 point increase at any study visit) relative to placebo

    Measured: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)

  4. Decrease in new decompensation events

    The effect of emricasan on decreasing new decompensation events relative to placebo

    Measured: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)

  5. Decrease in liver transplantation rates

    The effect of emricasan on decreasing liver transplantation rates (in association with MELD score ≥25) relative to placebo

    Measured: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)

  6. Decrease in all-cause and liver specific mortality

    The effect of emricasan on decreasing all-cause and liver specific mortality relative to placebo

    Measured: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)

  7. Improvement in health-related quality of life (QOL) as measured by Short Form-36

    Measured: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)

  8. Improvement in liver metabolic function as measured by Methacetin Breath Test (MBT)

    Measured: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jul 2017
  2. Study start28 Jun 2017
  3. Primary completionAug 2019 (estimated)
  4. Study completionAug 2019 (estimated)

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03205345
Sponsor's protocol ID
IDN-6556-17
Acronym
ENCORE-LF
Status last verified
Mar 2019
First submitted
20 Jun 2017
Last updated
19 Mar 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Frenette C, Kayali Z, Mena E, Mantry PS, Lucas KJ, Neff G, Rodriguez M, Thuluvath PJ, Weinberg E, Bhandari BR, Robinson J, Wedick N, Chan JL, Hagerty DT, Kowdley KV; IDN-6556-17 Study Investigators. Emricasan to prevent new decompensation in patients with NASH-related decompensated cirrhosis. J Hepatol. 2021 Feb;74(2):274-282. doi: 10.1016/j.jhep.2020.09.029. Epub 2020 Oct 8.

    PubMed 33038432

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Emricasan (25 mg) and Emricasan (5 mg) in people with Decompensated Cirrhosis, run by Conatus Pharmaceuticals Inc. at 76 sites 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: status not confirmed, as of the sponsor's last update on 19 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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?

Comparison of the effect of emricasan on improving event-free survival relative to placebo, based on a composite clinical endpoint (time frame: Baseline - Final Treatment Visit (at least 48 weeks to a max of 120 weeks)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03205345, which also lists 1 linked publication.

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 19 Mar 2019.

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