Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04806750
Other study ID # IDN-6556-14
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 17, 2016
Est. completion date April 8, 2019

Study information

Verified date April 2021
Source Histogen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multicenter, randomized, double-blind, placebo-controlled trial involving subjects with NASH cirrhosis and severe portal hypertension (defined as HVPG [hepatic venous pressure gradient] ≥12 mmHg as determined by the central reader assigned to this study). Upon successful screening, subjects will be randomized to receive either emricasan 50 mg BID (Bis in die, twice daily), 25 mg BID, or 5 mg BID or matching placebo BID.


Recruitment information / eligibility

Status Completed
Enrollment 263
Est. completion date April 8, 2019
Est. primary completion date October 2, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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.) - 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 (non-selective beta-blockers), 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: - Evidence of severe decompensation - 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 (QT interval corrected by the Fridericia Correction Formula) 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

Study Design


Intervention

Drug:
Emricasan

Placebo


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Histogen

References & Publications (1)

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(‡). Randomized placebo- — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Mean Change in Hepatic Venous Pressure Gradient (HVPG) To assess the mean change from baseline in hepatic venous pressure gradient (HVPG) Baseline to Week 24
Secondary Improvement of HVPG Response Using a 20 Percent Reduction From Baseline To assess the proportion of subjects who have at least a 20 percent reduction from baseline in HVPG Baseline to Week 24
Secondary Caspase 3/7 To assess whether emricasan compared to placebo decreases Caspase 3/7 biomarkers Baseline to Week 24, Baseline to Week 48
Secondary Alanine Aminotransferase (ALT) To assess whether emricasan compared to placebo decreases non-specific (ALT) biomarkers Baseline to Week 24 and Baseline to Week 48
See also
  Status Clinical Trial Phase
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05014594 - Sodium-glucose Linked Transporter 2 (SGLT-2) Inhibitors in Recurrent Ascites: a Pilot RCT Phase 2
Not yet recruiting NCT03631147 - The Effect of Rifaximin on Portal Vein Thrombosis N/A
Completed NCT04939350 - Evaluation of the Vaccination Coverage of Cirrhotic Patients Followed in the General Hospitals in France in 2021
Completed NCT02528760 - To Determine the Role of Prokinetics in Feed Intolerance in Critically Ill Cirrhosis N/A
Recruiting NCT05484206 - Effect of Hepatic Impairment on the Pharmacokinetics and Safety of VIR-2218 and VIR-3434 Phase 1
Not yet recruiting NCT05538546 - Baveno VI Criteria in Dynamic Monitoring of High-risk Varices in Compensated Cirrhotic Patients
Not yet recruiting NCT04053231 - Hepatocarcinoma Recurrence on the Liver Study - Part2
Recruiting NCT02983968 - Use of the French Healthcare Insurance Database
Completed NCT02705534 - Sofosbuvir, Ledipasvir, Ribavirin for Hepatitis C Cirrhotics, Genotype 1 Phase 3
Completed NCT02596880 - Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics Phase 3
Completed NCT02247414 - Warfarin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy and Azygoportal Disconnection Phase 4
Completed NCT02016196 - Rifaximin vs Placebo for the Prevention of Encephalopathy in Patients Treated by TIPS Phase 3
Withdrawn NCT01956864 - Study of High-Dose Oral Vitamin D for the Prevention of Liver Cancer Phase 1
Completed NCT01447537 - Mechanisms Involved in the Benefits of an Exercise Programme in Patients With Cirrhosis N/A
Completed NCT02113631 - Comparative Effectiveness and Tolerability of Boceprevir vs Telaprevir N/A
Completed NCT01362855 - Advance Care Planning Evaluation in Hospitalized Elderly Patients
Active, not recruiting NCT01205074 - ¹³C-Methacetin Breath Test (MBT) Methodology Study Phase 2/Phase 3
Completed NCT01476995 - Prognostic Indicators as Provided by the EPIC ClearView N/A
Completed NCT01231828 - Method of Assessment of Driving Ability in Patients Suffering From Wakefulness Pathologies. N/A