A Clinical trial to evaluate safety, and effectiveness of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
- Conditions
- onalcoholic Steatohepatitis (NASH)MedDRA version: 20.1 Level: PT Classification code 10053219 Term: Non-alcoholic steatohepatitis System Organ Class: 10019805 - Hepatobiliary disordersTherapeutic area: Diseases [C] - Digestive System Diseases [C06]
- Registration Number
- EUCTR2016-004148-13-PT
- Lead Sponsor
- Gilead Sciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 800
Subjects must meet all of the following inclusion criteria to be eligible for participation in this
study.
1) Willing and able to give informed consent prior to any study specific procedures being performed.
2) 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 cirrhosis (F4 fibrosis) according to the NASH CRN classification, in the opinion of the central reader.
3) Subject has the laboratory parameters at the Screening visit, as determined by the central laboratory.
4) Body Mass Index (BMI) = 18 kg/m2 at Screening.
5) Males and non-pregnant, non-lactating females between 18-70 years of age; inclusive based on the date of the Screening visit.
6) Females of childbearing potential must have a negative pregnancy test at Screening and Day 1.
7) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 720
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
1) Prior history of decompensated liver disease, including clinical ascites, HE, or variceal bleeding
2) CP score > 7, as determined at Screening, unless due to therapeutic
anti-coagulation.
3) MELD score > 12, as determined at Screening, unless due to therapeutic
anti-coagulation.
4) Chronic HBV infection (HBsAg positive).
5) 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.
6) 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/or centralized review of liver histology.
7) History of liver transplantation.
8) Current or history of HCC.
9) 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.
10) Weight loss > 10% within 6 months of Screening.
11) HIV infection (HIV Ab and HIV ribonucleic acid [HIV RNA] positive).
12) 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).
13) 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.
14) Unstable cardiovascular disease.
15) Use of any prohibited concomitant medication as described in Section 5.4. Subjects on Vitamin E must be on a stable dose for at least 6 months prior to the diagnostic liver biopsy and subjects on antidiabetic medications must be on a stable dose for at least 3 months prior to diagnostic liver biopsy.
16) History of a malignancy within 5 years of Screening.
17) Unable to safely undergo a liver biopsy.
18) 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.
19) Concurrent participation in another therapeutic clinical study.
20) Known hypersensitivity to SEL, the metabolites, or formulation excipient.
21) 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.
22) Presence of any condition th
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method