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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03053063
Registration number
NCT03053063
Ethics application status
Date submitted
10/02/2017
Date registered
14/02/2017
Titles & IDs
Public title
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
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Scientific title
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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Secondary ID [1]
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0
2016-004148-13
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Secondary ID [2]
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GS-US-384-1944
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Universal Trial Number (UTN)
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Trial acronym
STELLAR-4
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis
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0
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Condition category
Condition code
Oral and Gastrointestinal
0
0
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
0
0
0
0
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Metabolic disorders
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Diet and Nutrition
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0
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - SEL
Treatment: Drugs - Placebo to match SEL 6 mg
Treatment: Drugs - Placebo to match SEL 18 mg
Experimental: SEL 6 mg - Randomized Phase: SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks.
Open-Label (OL) Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
Experimental: SEL 18 mg - Randomized Phase: SEL 18 mg plus placebo to match SEL 6 mg for up to 240 weeks.
Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
Placebo comparator: Placebo - Randomized Phase: Placebo to match SEL 6 mg plus placebo to match SEL 18 mg for up to 240 weeks.
Open-Label Phase: Participants who experienced a hepatic clinical event during the randomized phase prior to completing the Week 240 visit, will be offered the option to receive OL SEL 18 mg daily for a total treatment duration of 240 weeks inclusive of the Randomized Phase.
Treatment: Drugs: SEL
Tablets administered orally once daily
Treatment: Drugs: Placebo to match SEL 6 mg
Tablets administered orally once daily
Treatment: Drugs: Placebo to match SEL 18 mg
Tablets administered orally once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of Participants Who Achieve a = 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH
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Assessment method [1]
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Fibrosis improvement was defined as = 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as = 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.
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Timepoint [1]
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Week 48
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Primary outcome [2]
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Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event
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Assessment method [2]
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EFS was assessed by the time to the first clinical event, including liver decompensation events, liver transplantation and all-cause mortality.
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Timepoint [2]
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Week 240
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Secondary outcome [1]
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Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240
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Assessment method [1]
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Fibrosis improvement was defined as = 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as = 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the NAS criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation.
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Timepoint [1]
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Week 240
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Secondary outcome [2]
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Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis at Week 48
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Assessment method [2]
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Fibrosis improvement was defined as = 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).
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Timepoint [2]
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Week 48
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Secondary outcome [3]
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Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis at Week 240
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Assessment method [3]
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Fibrosis improvement was defined as = 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis).
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Timepoint [3]
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Week 240
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Secondary outcome [4]
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Percentage of Participants Who Had NASH Resolution at Week 48
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Assessment method [4]
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NASH resolution was defined as lobular inflammation of 0 or 1 from = 1 at baseline and hepatocellular ballooning reduced to 0 from a value = 1 at baseline; both criteria were necessary conditions. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning = 1.
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Timepoint [4]
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Week 48
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Secondary outcome [5]
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Percentage of Participants Who Had NASH Resolution at Week 240
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Assessment method [5]
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NASH resolution was defined as lobular inflammation of 0 or 1 from = 1 at baseline and hepatocellular ballooning reduced to 0 from a value = 1 at baseline; both criteria were necessary conditions.As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning = 1.
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Timepoint [5]
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Week 240
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Eligibility
Key inclusion criteria
Key
* Liver biopsy consistent with NASH and cirrhosis (F4 fibrosis) according to the NASH Clinical Research Network (CRN) classification, in the opinion of the central reader
* Has the following laboratory parameters at the screening visit, as determined by the central laboratory:
* Alanine aminotransferase (ALT) = 8 x upper limit of normal (ULN)
* Creatinine Clearance (CLcr) = 30 milliliter/minute (mL/min), as calculated by the Cockcroft-Gault equation
* HbA1c = 9.5% (or serum fructosamine = 381 micromole (µmol) if HbA1c is unable to be resulted)
* International normalised ratio (INR) = 1.4, unless due to therapeutic anti-coagulation
* Platelet count = 100,000/µL
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Minimum age
18
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Maximum age
70
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Prior history of decompensated liver disease including clinical ascites, hepatic encephalopathy (HE), or variceal bleeding
* Child-Pugh (CP) score > 7, as determined at screening, unless due to therapeutic anti-coagulation
* Model for End-stage Liver Disease (MELD) score > 12, as determined at screening, unless due to therapeutic anti-coagulation
* Other causes of liver disease including, but not limited to, alcoholic liver disease, hepatitis B, hepatitis C, autoimmune disorders, drug-induced hepatotoxicity, Wilson disease, iron overload, and alpha-1-antitrypsin deficiency, based on medical history and/or centralized review of liver histology.
* History of liver transplantation
* Current or history of hepatocellular carcinoma (HCC)
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
30/01/2017
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
6/05/2019
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Sample size
Target
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Accrual to date
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Final
883
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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St. Vincent's Hospital Sydney - Darlinghurst
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St. George's Hospital - Kogarah
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Westmead Hospital - Westmead
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Royal Brisbane & Women's Hospital - Herston
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Royal Adelaide Hospital - Adelaide
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Lyell McEwin Hospital - Elizabeth Vale
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Monash Medical Centre - Clayton
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Austin Health - Heidelberg
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The Alfred Hospital, Alfred Health - Melbourne
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Sir Charles Gairdner Hospital - Nedlands
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Royal Perth Hospital - Perth
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2050 - Camperdown
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2010 - Darlinghurst
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2217 - Kogarah
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2145 - Westmead
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4029 - Herston
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5000 - Adelaide
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5112 - Elizabeth Vale
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3168 - Clayton
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3065 - Fitzroy
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3081 - Heidelberg
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3004 - Melbourne
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6009 - Nedlands
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Recruitment postcode(s) [13]
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6000 - Perth
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Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Ethics approval
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Summary
Brief summary
The primary objective of this study is to evaluate whether selonsertib (SEL; GS-4997) can cause fibrosis regression and reduce associated complications in adults with cirrhosis due to NASH.
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Trial website
https://clinicaltrials.gov/study/NCT03053063
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Trial related presentations / publications
Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-Gomez M, Okanoue T, Trauner M, Kersey K, Li G, Han L, Jia C, Wang L, Chen G, Subramanian GM, Myers RP, Djedjos CS, Kohli A, Bzowej N, Younes Z, Sarin S, Shiffman ML, Harrison SA, Afdhal NH, Goodman Z, Younossi ZM. Noninvasive Tests Accurately Identify Advanced Fibrosis due to NASH: Baseline Data From the STELLAR Trials. Hepatology. 2019 Nov;70(5):1521-1530. doi: 10.1002/hep.30842. Epub 2019 Aug 19. Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Romero-Gomez M, et al. Impact of age on routinely available noninvasive tests for the discrimination of advanced fibrosis due to NASH in the phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [Poster SAT-273]. European Association for the Study of the Liver (EASL); 2019; Vienna Austria. Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, Romero-Gomez M, Kersey K, Li G, Subramanian GM, Myers RP, Djedjos CS, Okanoue T, Trauner M, Goodman Z, Harrison SA. Reduced Patient-Reported Outcome Scores Associate With Level of Fibrosis in Patients With Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Nov;17(12):2552-2560.e10. doi: 10.1016/j.cgh.2019.02.024. Epub 2019 Feb 16. Anstee QM, Lawitz EJ, Alkhouri N, Wai Sun Wong V, Romero-Gomez M, et al. Routinely available noninvasive tests discriminate advanced fibrosis due to NASH in the Phase 3 STELLAR trials of the ASK1 inhibitor selonsertib [poster]. American Association for the Study of Liver Diseases (AASLD); 2018, San Francisco, CA. Younossi ZM, Lawitz E, Alkhouri N, Wong VWS, Romero-Gomez M, et al. Algorithms using noninvasive tests can accurately identify patients with advanced fibrosis due to NASH: Data From the STELLAR clinical trials [Poster LB-10]. AASLD; 2018; San Francisco, CA. Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai-Sun Wong V, et al. Severe impairment of patient-reported outcomes in patients with advanced fibrosis due to non-alcoholic steatohepatitis (NASH) [Poster]. AASLD; 2018; San Francisco, CA. Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wai Sun Wong V, et al. Advanced fibrosis based on noninvasive tests in nonalcoholic steatohepatitis (NASH) is associated with impairment of patient-reported outcomes [Poster]. AASLD; 2018; San Francisco, CA. Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppalanchi R, Younes Z, Kohli A, Sarin S, Caldwell SH, Alkhouri N, Shiffman ML, Camargo M, Li G, Kersey K, Jia C, Zhu Y, Djedjos CS, Subramanian GM, Myers RP, Gunn N, Sheikh A, Anstee QM, Romero-Gomez M, Trauner M, Goodman Z, Lawitz EJ, Younossi Z; STELLAR-3; STELLAR-4 Investigators. Selonsertib for patients with bridging fibrosis or compensated cirrhosis due to NASH: Results from randomized phase III STELLAR trials. J Hepatol. 2020 Jul;73(1):26-39. doi: 10.1016/j.jhep.2020.02.027. Epub 2020 Mar 6. Younossi ZM, Anstee QM, Wai-Sun Wong V, Trauner M, Lawitz EJ, Harrison SA, Camargo M, Kersey K, Subramanian GM, Myers RP, Stepanova M. The Association of Histologic and Noninvasive Tests With Adverse Clinical and Patient-Reported Outcomes in Patients With Advanced Fibrosis Due to Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Apr;160(5):1608-1619.e13. doi: 10.1053/j.gastro.2020.12.003. Epub 2020 Dec 8. Younossi ZM, Stepanova M, Younossi I, Racila A. Validation of Chronic Liver Disease Questionnaire for Nonalcoholic Steatohepatitis in Patients With Biopsy-Proven Nonalcoholic Steatohepatitis. Clin Gastroenterol Hepatol. 2019 Sep;17(10):2093-2100.e3. doi: 10.1016/j.cgh.2019.01.001. Epub 2019 Jan 11.
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Public notes
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Contacts
Principal investigator
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Gilead Study Director
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Gilead Sciences
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
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When will data be available (start and end dates)?
18 months after study completion
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Available to whom?
A secured external environment with username, password, and RSA code.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
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What supporting documents are/will be available?
No Supporting Document Provided
Type
Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/63/NCT03053063/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/63/NCT03053063/SAP_001.pdf
Results publications and other study-related documents
Type
Citations or Other Details
Journal
Anstee QM, Lawitz EJ, Alkhouri N, Wong VW, Romero-...
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Journal
Alkhouri N, Younossi ZM, Lawitz EJ, Wong VWS, Rome...
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Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wa...
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Anstee QM, Lawitz EJ, Alkhouri N, Wai Sun Wong V, ...
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Younossi ZM, Lawitz E, Alkhouri N, Wong VWS, Romer...
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Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wa...
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Younossi ZM, Stepanova M, Anstee QM, Lawitz EJ, Wa...
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Journal
Harrison SA, Wong VW, Okanoue T, Bzowej N, Vuppala...
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Results not provided in
https://clinicaltrials.gov/study/NCT03053063