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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT03053050
Registration number
NCT03053050
Ethics application status
Date submitted
10/02/2017
Date registered
14/02/2017
Date last updated
29/06/2020
Titles & IDs
Public title
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
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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 Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
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Secondary ID [1]
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2016-004374-18
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Secondary ID [2]
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GS-US-384-1943
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Universal Trial Number (UTN)
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Trial acronym
STELLAR-3
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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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Condition category
Condition code
Oral and Gastrointestinal
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
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0
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Metabolic disorders
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Diet and Nutrition
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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 18 mg - Randomized Phase: Selonsertib (SEL) 18 mg tablet + placebo to match SEL 6 mg tablet for 240 weeks
Open-Label (OL) Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
Experimental: SEL 6 mg - Randomized Phase: SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks
OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg for a total treatment duration of 240 weeks inclusive of the randomized phase.
Placebo Comparator: Placebo - Randomized Phase: Placebo to match SEL 6 mg tablet + placebo to match SEL 18 mg tablet for 240 weeks
OL Phase: Participants who experience a hepatic clinical event or have biopsy confirmed progression to cirrhosis during the randomized phase, prior to completing the Week 240 visit, will be offered the option to roll over into an OL phase to receive OL SEL 18 mg 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 Achieved a = 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48
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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 progression to cirrhosis on liver biopsy, 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 Progression to Cirrhosis at Week 48
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Assessment method [1]
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Progression to cirrhosis was defined as a change in NASH CRN fibrosis stage from < 4 at baseline to 4 at Week 48.
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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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 [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). 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 [2]
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Week 240
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Secondary outcome [3]
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Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis at Week 48
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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 48
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Secondary outcome [4]
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Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis at Week 240
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Assessment method [4]
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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 [4]
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Week 240
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Secondary outcome [5]
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Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48
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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 of 1 from a value = 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning = 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.
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Timepoint [5]
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Week 48
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Secondary outcome [6]
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Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240
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Assessment method [6]
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NASH resolution was defined as lobular inflammation of 0 or 1 from = 1 at baseline and hepatocellular ballooning of 1 from a value = 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning = 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN.
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Timepoint [6]
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Week 240
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Eligibility
Key inclusion criteria
Key
- Liver biopsy consistent with NASH and bridging (F3 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:
- 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
- Hemoglobin A1c (HbA1c) = 9.5% (or serum fructosamine = 381 µmol if HbA1c is
unable to be resulted)
- Total bilirubin = 1.3 x ULN (unless an alternate etiology such as Gilbert's
syndrome or hemolytic anemia is present)
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Minimum age
18
Years
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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 > 6, 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-antitryspin 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
Terminated
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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
13/02/2017
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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
19/06/2019
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Sample size
Target
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Accrual to date
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Final
808
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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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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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Monash Health, Monash Medical Centre - Clayton
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St. Vincent's Hospital Melbourne - Fitzroy
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Austin Hospital - Heidelberg
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The Alfred Hospital, Alfred Health - Melbourne
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Recruitment hospital [10]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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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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3168 - Clayton
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3065 - Fitzroy
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3084 - Heidelberg
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3004 - Melbourne
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Recruitment postcode(s) [10]
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6000 - Perth
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Recruitment outside Australia
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Japan
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State/province [101]
0
0
Minato
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Country [102]
0
0
Japan
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State/province [102]
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0
Miyazaki
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Country [103]
0
0
Japan
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State/province [103]
0
0
Musashino
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Country [104]
0
0
Japan
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State/province [104]
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0
Nagakute
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Country [105]
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0
Japan
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State/province [105]
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0
Nakagami
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Country [106]
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0
Japan
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State/province [106]
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0
Nara
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Country [107]
0
0
Japan
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State/province [107]
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0
Nishinomiya
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Country [108]
0
0
Japan
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State/province [108]
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Okayama
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Country [109]
0
0
Japan
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State/province [109]
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0
Osaka
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Country [110]
0
0
Japan
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State/province [110]
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0
Saga
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Country [111]
0
0
Japan
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State/province [111]
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0
Sapporo
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Country [112]
0
0
Japan
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State/province [112]
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0
Sendai
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Country [113]
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0
Japan
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State/province [113]
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0
Shinjuku-ku
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Country [114]
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0
Japan
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State/province [114]
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Suita
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Country [115]
0
0
Japan
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State/province [115]
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0
Takamatsu
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Country [116]
0
0
Japan
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State/province [116]
0
0
Tsu
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Country [117]
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0
Japan
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State/province [117]
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0
Tono
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Country [118]
0
0
Japan
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State/province [118]
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0
Yamagata
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Country [119]
0
0
Japan
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State/province [119]
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0
Yokohama
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Country [120]
0
0
Japan
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State/province [120]
0
0
Omura
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Country [121]
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0
Korea, Republic of
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State/province [121]
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0
Daegu
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Country [122]
0
0
Korea, Republic of
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State/province [122]
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0
Goyang-si
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Country [123]
0
0
Korea, Republic of
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State/province [123]
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0
Seoul
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Country [124]
0
0
Korea, Republic of
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State/province [124]
0
0
Wonju
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Country [125]
0
0
Malaysia
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State/province [125]
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0
Batu Caves
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Country [126]
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0
Malaysia
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State/province [126]
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0
Kuala Lumpur
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Country [127]
0
0
Mexico
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State/province [127]
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0
Cuautitlán
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Country [128]
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0
Mexico
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State/province [128]
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Mexico City
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Country [129]
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Mexico
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State/province [129]
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0
Monterrey
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Country [130]
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0
Netherlands
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State/province [130]
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0
Utrecht
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Country [131]
0
0
New Zealand
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State/province [131]
0
0
Grafton
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Country [132]
0
0
Poland
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State/province [132]
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0
Bytom
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Country [133]
0
0
Poland
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State/province [133]
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0
Lódz
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Country [134]
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0
Portugal
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State/province [134]
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Vila Real
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Country [135]
0
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Puerto Rico
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State/province [135]
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San Juan
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Country [136]
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Singapore
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State/province [136]
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Singapore
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Country [137]
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0
Spain
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State/province [137]
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Barcelona
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Country [138]
0
0
Spain
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State/province [138]
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Madrid
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Country [139]
0
0
Spain
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State/province [139]
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Majadahonda
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Country [140]
0
0
Spain
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State/province [140]
0
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Pontevedra
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Country [141]
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0
Spain
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State/province [141]
0
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Santander
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Country [142]
0
0
Spain
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State/province [142]
0
0
Sevilla
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Country [143]
0
0
Spain
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State/province [143]
0
0
Valencia
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Country [144]
0
0
Switzerland
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State/province [144]
0
0
Bern
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Country [145]
0
0
Switzerland
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State/province [145]
0
0
Lugano
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Country [146]
0
0
Taiwan
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State/province [146]
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0
Chang-hua
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Country [147]
0
0
Taiwan
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State/province [147]
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0
Chiayi City
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Country [148]
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0
Taiwan
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State/province [148]
0
0
Kaohsiung
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Country [149]
0
0
Taiwan
Query!
State/province [149]
0
0
Keelung
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Country [150]
0
0
Taiwan
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State/province [150]
0
0
Taichung
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Country [151]
0
0
Taiwan
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State/province [151]
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0
Tainan
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Country [152]
0
0
Taiwan
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State/province [152]
0
0
Taipei
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Country [153]
0
0
Taiwan
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State/province [153]
0
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Taoyuan
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Country [154]
0
0
United Kingdom
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State/province [154]
0
0
Cambridge
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Country [155]
0
0
United Kingdom
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State/province [155]
0
0
Derby
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Country [156]
0
0
United Kingdom
Query!
State/province [156]
0
0
Edgbaston
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Country [157]
0
0
United Kingdom
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State/province [157]
0
0
London
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Country [158]
0
0
United Kingdom
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State/province [158]
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0
Newcastle upon Tyne
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Country [159]
0
0
United Kingdom
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State/province [159]
0
0
Norwich
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Country [160]
0
0
United Kingdom
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State/province [160]
0
0
Nottingham
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Country [161]
0
0
United Kingdom
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State/province [161]
0
0
Portsmouth
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Country [162]
0
0
United Kingdom
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State/province [162]
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0
Swansea
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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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 progression to cirrhosis and associated complications in
adults with NASH and bridging (F3) fibrosis.
Query!
Trial website
https://clinicaltrials.gov/ct2/show/NCT03053050
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Gilead Study Director
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Address
0
0
Gilead Sciences
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0
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Phone
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0
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT03053050
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