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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/NCT03053063




Registration number
NCT03053063
Ethics application status
Date submitted
10/02/2017
Date registered
14/02/2017
Date last updated
7/05/2020

Titles & IDs
Public title
Safety and Efficacy of Selonsertib in Adults With Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
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)
Secondary ID [1] 0 0
2016-004148-13
Secondary ID [2] 0 0
GS-US-384-1944
Universal Trial Number (UTN)
Trial acronym
STELLAR-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 0 0 0 0
Metabolic disorders
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Week 48
Primary outcome [2] 0 0
Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event
Timepoint [2] 0 0
Week 240
Secondary outcome [1] 0 0
Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240
Timepoint [1] 0 0
Week 240
Secondary outcome [2] 0 0
Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis at Week 48
Timepoint [2] 0 0
Week 48
Secondary outcome [3] 0 0
Percentage of Participants Who Had a = 1-Stage Improvement in Fibrosis at Week 240
Timepoint [3] 0 0
Week 240
Secondary outcome [4] 0 0
Percentage of Participants Who Had NASH Resolution at Week 48
Timepoint [4] 0 0
Week 48
Secondary outcome [5] 0 0
Percentage of Participants Who Had NASH Resolution at Week 240
Timepoint [5] 0 0
Week 240

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

Key
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
6/05/2019
Sample size
Target
Accrual to date
Final
883
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
St. Vincent's Hospital Sydney - Darlinghurst
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St. George's Hospital - Kogarah
Recruitment hospital [4] 0 0
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
Recruitment hospital [8] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [9] 0 0
St. Vincent's Hospital Melbourne - Fitzroy
Recruitment hospital [10] 0 0
Austin Health - Heidelberg
Recruitment hospital [11] 0 0
The Alfred Hospital, Alfred Health - Melbourne
Recruitment hospital [12] 0 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment hospital [13] 0 0
Royal Perth Hospital - Perth
Recruitment postcode(s) [1] 0 0
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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6000 - Perth
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT03053063
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT03053063