Clinical Trials List
2017-03-17 - 2023-03-17
Phase III
Terminated4
ICD-10K75.81
Nonalcoholic steatohepatitis (NASH)
ICD-9571.8
Other chronic nonalcoholic liver disease
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Selonsertib in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (NASH)
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Trial Applicant
GILEAD SCIENCES HONG KONG LIMITED
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Sponsor
Gilead Sciences
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 邱彥程 Division of General Internal Medicine
- Chiu Hung Chiu Division of General Internal Medicine
- 簡世杰 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Audit
None
Taiwan National PI
Co-Principal Investigator
- Chun-Yen Lin Division of General Internal Medicine
- 李承翰 Division of General Internal Medicine
- 何玉彬 Division of General Internal Medicine
- Yi-Cheng Chen Division of General Internal Medicine
- Wen-Juei Jeng Division of General Internal Medicine
- 鄭雅婷 Division of General Internal Medicine
- Rong-Nan Chien Division of General Internal Medicine
- 陳威廷 Division of General Internal Medicine
- 滕威 Division of General Internal Medicine
- Chen-Chun Lin Division of General Internal Medicine
- Chien-Hao Huang Division of General Internal Medicine
- Yi-Chung Hsieh Division of General Internal Medicine
- 戴達英 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
2 Stop recruiting
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Chun-Jen Liu Digestive System Department
- Chen-Hua Liu Digestive System Department
- 楊宏志 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Co-Principal Investigator
- Wan-Long Chuang Digestive System Department
- 黃駿逸 Digestive System Department
- Ming-Lung Yu Digestive System Department
- Chia-Yen Dai Digestive System Department
- Chung-Feng Huang Digestive System Department
- Ming-Lun Yeh Digestive System Department
The Actual Total Number of Participants Enrolled
0 Stop recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
The primary efficacy endpoint at Week 48 includes theproportion of subjects who achieve a ≥ 1-stage improvement in fibrosis (according to the NASH CRN classification) without worsening of NASH (defined as a ≥ 1-point increase in hepatocellular ballooning or lobular inflammation).
The clinical efficacy endpoint at Week 240 is event-free survival (EFS). EFS will be assessed by time to the first clinical event including liver decompensation events, HCC, liver transplantation, or death.
Secondary Endpoints:
• Proportion of subjects who have a ≥ 1-stage improvement in fibrosis without worsening of NASH at Week 240;
• Proportion of subjects who have a ≥ 1-stage improvement in fibrosis at Week 48 and Week 240;
• Proportion of subjects who have NASH resolution at Week 48 and Week 240.
2. Safety:
The safety of SEL in subjects with cirrhosis due to NASH will be assessed during the study through the reporting of AEs, clinical laboratory tests, vital sign assessments and concomitant medication usage.
An external Data Monitoring Committee (DMC) that consists of three hepatologists and a PhD statistician will review the progress of the study.
They will convene after 50 subjects have completed the Week 4 visit and approximately every 6 months thereafter to monitor the study for safety events.
3. Pharmacokinetics:
Plasma concentrations of SEL and GS-607509 will be listed and summarized.
For the PK substudy, PK parameters will be listed and summarized for SEL and GS-607509 using descriptive statistics.
4. Quality of life: EuroQol five dimensions [EQ-5D]
Inclution Criteria
grade 1 steatosis, hepatocellular ballooning, and lobular inflammation
according to the NAFLD Activity Score [NAS]) and cirrhosis (F4 fibrosis)
according to the NASH Clinical Research Network (CRN) classification, in
the opinion of the centralreader.
a) A historical liver biopsy within 12 months of the Screening visit may be
accepted as the Screening biopsy if the sample is deemed acceptable for
interpretation by the central reader.
b) If a subject is deemed ineligible for this study, the liver biopsy, if
performed according to protocol specifications and is within 6 months of
the Screening visit, may be used to determine eligibility for study GS-US-384-1943.
2) Subject has the following laboratory parameters at the Screening visit, as
determined by the centrallaboratory:
a) Alanine aminotransferase (ALT) ≤ 8 x ULN
b) Creatinine Clearance (CLcr) ≥ 30 milliliter/minute (mL/min), as calculated
by the Cockcroft-Gault equation
c) HbA1c ≤ 9.5%
Exclusion Criteria
variceal bleeding
2) CP score > 7, as determined atScreening
3) MELD score > 12, as determined at Screening
4) Chronic hepatitis B virus (HBV) infection (hepatitis B surface antigen
[HBsAg] positive)
5) Chronic hepatitis C virus (HCV) infection (HCV Ab and HCV ribonucleic acid
[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 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 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) Human immunodeficiency virus (HIV)infection
12) Unstable cardiovascular disease
The Estimated Number of Participants
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Taiwan
20 participants
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Global
800 participants
