A Study of the Safety and Effectiveness of Experimental Selonsertib, GS-0976, and GS-9674 for NASH (non-alcoholic fatty liver)

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"Volunteer for research at UC Davis and contribute to discoveries that may improve health care for you, your family, and your community!"
Age: 18 to 80 years old
Gender:
Any
Healthy Volunteers: No
Keywords: NASH, Nonalcoholic Steatohepatitis, liver, fatty liver
Type: Drug study, Phase 2
Target:
5 Participants
Investigator:
Description
You have been asked to take part in a clinical research study. This study will test the experimental drugs named Selonsertib (also known as “SEL”), GS-0976, GS-9674, and combinations of these experimental drugs. They will be used for the treatment of nonalcoholic steatohepatitis (NASH). NASH is a more severe form of nonalcoholic fatty liver disease (NAFLD). The liver becomes fatty, inflamed and liver cells become injured. Scarring of the liver (fibrosis) may also occur.

These drugs have not been approved by the Food and Drug Administration (FDA). Experimental drugs like SEL, GS- 0976, GS-9674, and combinations of these drugs may be tested in research studies such as this one.

The purpose of this study is to see if SEL, GS-0976, GS-9674, and combinations of these drugs are safe and well-tolerated. Researchers hope they can reduce fibrosis and the associated complications in subjects with fibrosis due to NASH.
This study requires

The study team will make sure you qualify to take part in the study. Qualified participants will receive detailed information about the study. This may include a list of study-related tests and procedures.

Who can participate

Inclusion criteria:

  • Liver biopsy consistent with NASH and bridging fibrosis (F3) and cirrhosis (F4) in the opinion of the central reader
  • In participants who have never had a liver biopsy, liver stiffness by FibroScan® and Enhanced Liver Fibrosis (ELF™) Test score at Screening
  • Screening laboratory parameters, as determined by the central laboratory:
  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/min, as calculated by the Cockcroft-Gault equation
  • HbA1c ≤ 9.5%
  • Alanine aminotransferase (ALT) < 5 x Upper Limits of Normal (ULN)
  • Platelet count ≥ 125,000/μL Key

Exclusion criteria:

  • Prior history of decompensated liver disease including ascites, hepatic encephalopathy, or variceal bleeding
  • Child-Pugh (CP) score > 6 at Screening, unless due to an alternative etiology such as Gilbert's syndrome or therapeutic anticoagulation
  • Model for End-Stage Liver Disease (MELD) score > 12 at Screening, unless due to an alternate etiology such as therapeutic anticoagulation
  • Other causes of liver disease based on medical history and/or centralized review of liver histology, including but not limited to: alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders (eg, primary biliary cholangitis, primary sclerosing cholangitis, autoimmune hepatitis), drug-induced hepatotoxicity, Wilson disease, clinically significant iron overload, or alpha-1-antitrypsin deficiency requiring treatment
  • History of liver transplantation
  • Current or prior history of hepatocellular carcinoma Note: Other protocol defined Inclusion/ Exclusion criteria may apply
Benefits and risks of participating
BENEFITS:

We cannot promise any benefits to you as a result of taking part in this research study.


RISKS:

The study doctor will discuss the risks associated with taking part in this research study.
Compensation
If you agree to take part in this research study, we will compensate you $65.00 for your time and effort for each completed visit. If you quit the study, you will receive a partial amount based on how many study visits you completed.
Resources
Schedule
Study duration and period
You will be in this research study up to 60 weeks. This includes an 8-week Screening period, a 48-week On-Treatment period, and a 4-week Follow-Up period. During this time, you will be required to visit the clinic at least 16 times.
Recruitment period
From June 20, 2018
Location
UC Davis Medical Center
2315 Stockton Boulevard
Sacramento, CA 95817
Contact
Sophia Zaragoza
Research Topic
Conditions:
  • Nonalcoholic Steatohepatitis