A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

  • STATUS
    Recruiting
  • sponsor
    Gilead Sciences, Inc.
Updated on 25 March 2021

Summary

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis

Description

The primary objective of this study is to evaluate whether SEL can cause fibrosis regression and reduce progression to cirrhosis and associated complications in subjects with NASH and bridging (F3) fibrosis.

The secondary objective of this study is to assess the safety and tolerability of SEL in subjects with NASH and bridging (F3) fibrosis.

Details
Clinical Study IdentifierTX150739
SponsorGilead Sciences, Inc.
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Willing and able to give informed consent prior to any study specific procedures being performed
Liver biopsy consistent with NASH (defined as the presence of at least grade 1 steatosis, hepatocellular ballooning, and lobular inflammation according to the NAFLD Activity Score [NAS]) and bridging (F3 fibrosis) according to the NASH CRN classification, in the opinion of the central reader
A historical liver biopsy within 6 months of the Screening visit may be accepted as the Screening biopsy if the sample is deemed acceptable for interpretation by the central reader
If the subject is deemed ineligible for this study, the liver biopsy, if performed according to protocol specifications and is within 12 months of the Screening visit, may be used to determine eligibility for study GS-US-384-1944
Subject has the following laboratory parameters at the Screening visit, as determined by the central laboratory
ALT ≤ 8 x ULN
CLcr = 30 mL/min, as calculated by the Cockcroft-Gault equation
HbA1c ≤ 9.5%
Total bilirubin ≤ 1.5 x ULN
Body Mass Index (BMI) = 18 kg/m2 at Screening
Males and non-pregnant, non-lactating females between 18-70 years of age; inclusive based on the date of the Screening visit
Females of childbearing potential must have a negative pregnancy test at Screening and Day 1
Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria

Prior history of decompensated liver disease, including ascites, HE, or variceal bleeding
CP score > 6, as determined at Screening
MELD score > 12, as determined at Screening
Chronic HBV infection (HBsAg positive)
Chronic HCV infection (HCV Ab and HCV RNA positive). Subjects cured of HCV infection less than 5 years prior to the Screening visit are not eligible
Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (e.g., primary biliary cholangitis, primary sclerosing cholangitis, and autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitryspin deficiency, based on medical history and centralized review of liver histology
History of liver transplantation
Current or history of HCC
Any weight reduction surgery in the 2 years prior to Screening or planned during the study (weight reduction surgery is disallowed during the study), and malabsorptive weight loss surgery (e.g., Roux-en-Y or distal gastric bypass) at any time prior to Screening
Weight loss > 10% within 6 months of Screening
HIV infection (HIV Ab and HIV ribonucleic acid [HIV RNA] positive)
Current alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1oz/30mL of alcohol is present in 1 12oz/360mL beer, 1 4oz/120mL glass of wine, and a 1 oz/30 mL measure of 40 proof alcohol)
Positive urine drug screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at Screening. Subjects on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included in the study. Subjects with a positive urine drug screen due to prescription opioid-based medication are eligible if the prescription and diagnosis are reviewed and approved by the investigator
Unstable cardiovascular disease as defined by any of the following
Unstable angina, myocardial infarction, coronary artery bypass graft surgery or coronary angioplasty within 6 months prior to Screening
Transient ischemic attack or cerebrovascular accident within 6 months prior to Screening
Symptomatic obstructive valvular heart disease or hypertrophic cardiomyopathy
Congestive heart failure
Use of any prohibited concomitant medication. Subjects on Vitamin E must be on a stable dose for at least 6 months prior to Day 1 and subjects on thiazolidinediones (TZDs) must be on a stable dose for at least 3 months prior to Day 1
History of a malignancy within 5 years of Screening with the following exceptions
Adequately treated carcinoma in situ of the cervix
Adequately treated basal or squamous cell cancer or other localized non-melanoma skin cancer
Unable to safely undergo a liver biopsy
Participation in another investigational study of a drug or device within 30 days or within 5 half-lives of the prior investigational agent (whichever is longer) prior to Screening
Concurrent participation in another therapeutic clinical study
Known hypersensitivity to SEL, the metabolites, or formulation excipient
Any laboratory abnormality or condition that, in the investigator’s opinion, could adversely affect the safety of the subject or impair the assessment of study results
Presence of any condition that could, in the opinion of the investigator, compromise the subject’s ability to participate in the study, including a history of substance abuse or a psychiatric condition requiring hospitalization or emergency room visit within 2 years of Screening
Unavailable for follow-up assessment or concern for subject’s compliance with the protocol procedures
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