Emricasan, an Oral Caspase Inhibitor, in Subjects With NASH Cirrhosis and Severe Portal Hypertension
NCT ID: NCT02960204
Last Updated: 2022-02-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
263 participants
INTERVENTIONAL
2016-10-17
2019-04-08
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Emricasan (5 mg)
Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (5 mg) twice a day.
Emricasan
Emricasan (25 mg)
Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (25 mg) twice a day.
Emricasan
Emricasan (50 mg)
Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with emricasan (50 mg) twice a day.
Emricasan
Matching Placebo
Subjects with Non-alcoholic Steatohepatitis (NASH) Cirrhosis and Severe Portal Hypertension will be administered orally with a matching placebo twice a day.
Placebo
Interventions
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Emricasan
Placebo
Eligibility Criteria
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Inclusion Criteria
* Cirrhosis due to NASH with exclusion of other causes of cirrhosis (e.g. chronic viral hepatitis, alcoholic liver disease, etc.)
* Compensated cirrhosis OR Decompensated cirrhosis with no more than 1 prior significant decompensating event
* Severe portal hypertension defined as HVPG ≥12 mmHg
* Subjects who are on NSBB, nitrates, diuretics, lactulose, rifaximin, or statins must be on a stable dose for at least 3 months prior to Day 1
* Willingness to utilize effective contraception (for both males and females of childbearing potential) from Screening to 4 weeks after the last dose of study drug
Exclusion Criteria
* Severe hepatic impairment defined as a Child-Pugh score ≥10
* ALT (alanine transaminase) \> 3 times upper limit of normal (ULN) or AST (aspartate transaminase) \>5 times ULN during screening
* Estimated creatinine clearance \<30 mL/min
* Prior transjugular intrahepatic portosystemic shunt or other porto-systemic bypass procedure
* Known portal vein thrombosis
* Symptoms of biliary colic, e.g. due to symptomatic gallstones, within the last 6 months, unless resolved following cholecystectomy
* Current use of medications that are considered inhibitors of OATP1B1 and OATP1B3 transporters
* Alpha-fetoprotein \>50 ng/mL
* History or presence of clinically concerning cardiac arrhythmias, or prolongation of screening (pre-treatment) QTcF interval of \>500 msec
* History of or active malignancies, other than those successfully treated with curative intent and believed to be cured
* Prior liver transplant
* Change in diabetes medications or vitamin E within 3 months of screening
* Uncontrolled diabetes mellitus (HbA1c \>9%) within 3 months of screening
* Significant systemic or major illness other than liver disease
* HIV infection
* Use of controlled substances (including inhaled or injected drugs) or non-prescribed use of prescription drugs within 1 year of screening
* If female: planned or known pregnancy, positive urine or serum pregnancy test, or lactating/breastfeeding
* Previous treatment with emricasan or active investigational medication (except methacetin) in a clinical trial within 3 months prior to Day 1
18 Years
ALL
No
Sponsors
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Histogen
INDUSTRY
Responsible Party
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Principal Investigators
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Jeanette M Wetzel
Role: STUDY_DIRECTOR
Histogen
Samuel Mboggo
Role: STUDY_DIRECTOR
Histogen
Ruqayyah Abdulrahoof
Role: STUDY_DIRECTOR
Histogen
Locations
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Pasadena
Pasadena, California, United States
Rialto
Rialto, California, United States
Palmetto Bay
Palmetto Bay, Florida, United States
Atlanta
Atlanta, Georgia, United States
Clive
Clive, Iowa, United States
Baltimore
Baltimore, Maryland, United States
Detroit
Detroit, Michigan, United States
Rochester
Rochester, Minnesota, United States
Saint Paul
Saint Paul, Minnesota, United States
Kansas City
Kansas City, Missouri, United States
Durham
Durham, North Carolina, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Philadelphia
Philadelphia, Pennsylvania, United States
Germantown
Germantown, Tennessee, United States
Arlington
Arlington, Texas, United States
Houston
Houston, Texas, United States
San Antonio
San Antonio, Texas, United States
San Antonio
San Antonio, Texas, United States
Norfolk
Norfolk, Virginia, United States
Richmond
Richmond, Virginia, United States
Richmond
Richmond, Virginia, United States
Seattle, Washington
Seattle, Washington, United States
Bonn
Bonn, , Germany
Halle (Saale)
Halle, , Germany
Leipzig
Leipzig, , Germany
Mainz
Mainz, , Germany
Münster
Münster, , Germany
Barcelona
Barcelona, , Spain
Barcelona
Barcelona, , Spain
San Sebastian
Donostia / San Sebastian, , Spain
Madrid
Madrid, , Spain
Madrid
Madrid, , Spain
Madrid
Madrid, , Spain
Majadahonda
Majadahonda, , Spain
Santander
Santander, , Spain
Valencia
Valencia, , Spain
Valencia
Valencia, , Spain
Countries
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References
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Garcia-Tsao G, Bosch J, Kayali Z, Harrison SA, Abdelmalek MF, Lawitz E, Satapathy SK, Ghabril M, Shiffman ML, Younes ZH, Thuluvath PJ, Berzigotti A, Albillos A, Robinson JM, Hagerty DT, Chan JL, Sanyal AJ; IDN-6556-14 Investigators(double dagger). Randomized placebo-controlled trial of emricasan for non-alcoholic steatohepatitis-related cirrhosis with severe portal hypertension. J Hepatol. 2020 May;72(5):885-895. doi: 10.1016/j.jhep.2019.12.010. Epub 2019 Dec 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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IDN-6556-41
Identifier Type: -
Identifier Source: org_study_id
NCT04806750
Identifier Type: -
Identifier Source: nct_alias
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