Status:
TERMINATED
Companion Protocol for Methacetin Breath Test (MBT) in Conatus Protocol IDN-6556-17
Lead Sponsor:
Meridian Bioscience, Inc.
Collaborating Sponsors:
Conatus Pharmaceuticals Inc.
Conditions:
Decompensated Cirrhosis
Eligibility:
All Genders
18+ years
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-con...
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 N...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
June 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2019
Estimated Enrollment :
199 Patients enrolled
Trial Details
Trial ID
NCT03462576
Start Date
June 28 2017
End Date
July 15 2019
Last Update
December 20 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida Digestive Health Specialists Research Institute
Lakewood Rch, Florida, United States, 34211