Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17

NCT03462576 | Terminated Results

• 1 other identifier: CON-EX-0217
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Decompensated Cirrhosis

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  1 hour for MBT for assessment of this diagnostic outcome assessed during screening

Study Arms (3)

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.

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.

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.

Combination Product: Methacetin Breath Test; Drug: Placebo oral capsule

Interventions

Methacetin Breath Test COMBINATION_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.

Emricasan 25mg; Emricasan 5mg; Placebo

Emricasan DRUG

Investigational drug for NASH treatment in Main Conatus protocol

Emricasan 25mg; Emricasan 5mg

Placebo oral capsule DRUG

Placebo versus emricasan in Conatus NASH treatment trial

Placebo

Eligibility Criteria

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

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Meridian Bioscience, Inc.: lead
• Conatus Pharmaceuticals Inc.: collaborator

Study Sites (1)

Florida Digestive Health Specialists Research Institute

Lakewood Rch, Florida, 34211, United States

Location

MeSH Terms

Interventions

3-(2-(2-tert-butylphenylaminooxalyl)aminopropionylamino)-4-oxo-5-(2,3,5,6-tetrafluorophenoxy)pentanoic acid

Results Point of Contact

• Title: Avrahm Hershkowitz/ Clinical Trial Manager
• Organization: Exalenz Bioscience

avrahamh@exalenz.com

972-8-9737513

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The collaborator is responsible for the masking process.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 6, 2018
• First Posted: March 12, 2018
• Study Start: June 28, 2017
• Primary Completion: July 15, 2019
• Study Completion: July 15, 2019
• Last Updated: December 20, 2022
• Results First Posted: December 16, 2020

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)