Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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)
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
Stopped early
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
Recruitment hospital [3] 0 0
St. George's Hospital - Kogarah
Recruitment hospital [4] 0 0
Westmead Hospital - Westmead
Recruitment hospital [5] 0 0
Royal Brisbane & Women's Hospital - Herston
Recruitment hospital [6] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [7] 0 0
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
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
2217 - Kogarah
Recruitment postcode(s) [4] 0 0
2145 - Westmead
Recruitment postcode(s) [5] 0 0
4029 - Herston
Recruitment postcode(s) [6] 0 0
5000 - Adelaide
Recruitment postcode(s) [7] 0 0
5112 - Elizabeth Vale
Recruitment postcode(s) [8] 0 0
3168 - Clayton
Recruitment postcode(s) [9] 0 0
3065 - Fitzroy
Recruitment postcode(s) [10] 0 0
3081 - Heidelberg
Recruitment postcode(s) [11] 0 0
3004 - Melbourne
Recruitment postcode(s) [12] 0 0
6009 - Nedlands
Recruitment postcode(s) [13] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Georgia
Country [7] 0 0
United States of America
State/province [7] 0 0
Illinois
Country [8] 0 0
United States of America
State/province [8] 0 0
Indiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Iowa
Country [10] 0 0
United States of America
State/province [10] 0 0
Kansas
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Maryland
Country [14] 0 0
United States of America
State/province [14] 0 0
Massachusetts
Country [15] 0 0
United States of America
State/province [15] 0 0
Michigan
Country [16] 0 0
United States of America
State/province [16] 0 0
Minnesota
Country [17] 0 0
United States of America
State/province [17] 0 0
Mississippi
Country [18] 0 0
United States of America
State/province [18] 0 0
Missouri
Country [19] 0 0
United States of America
State/province [19] 0 0
New Jersey
Country [20] 0 0
United States of America
State/province [20] 0 0
New Mexico
Country [21] 0 0
United States of America
State/province [21] 0 0
New York
Country [22] 0 0
United States of America
State/province [22] 0 0
North Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
Rhode Island
Country [26] 0 0
United States of America
State/province [26] 0 0
South Carolina
Country [27] 0 0
United States of America
State/province [27] 0 0
Tennessee
Country [28] 0 0
United States of America
State/province [28] 0 0
Texas
Country [29] 0 0
United States of America
State/province [29] 0 0
Utah
Country [30] 0 0
United States of America
State/province [30] 0 0
Vermont
Country [31] 0 0
United States of America
State/province [31] 0 0
Virginia
Country [32] 0 0
United States of America
State/province [32] 0 0
Washington
Country [33] 0 0
Austria
State/province [33] 0 0
Graz
Country [34] 0 0
Austria
State/province [34] 0 0
Vienna
Country [35] 0 0
Belgium
State/province [35] 0 0
Brussels
Country [36] 0 0
Belgium
State/province [36] 0 0
Bruxelles
Country [37] 0 0
Belgium
State/province [37] 0 0
Ghent
Country [38] 0 0
Belgium
State/province [38] 0 0
Leuven
Country [39] 0 0
Canada
State/province [39] 0 0
Alberta
Country [40] 0 0
Canada
State/province [40] 0 0
British Columbia
Country [41] 0 0
Canada
State/province [41] 0 0
Manitoba
Country [42] 0 0
Canada
State/province [42] 0 0
Nova Scotia
Country [43] 0 0
Canada
State/province [43] 0 0
Ontario
Country [44] 0 0
Canada
State/province [44] 0 0
Quebec
Country [45] 0 0
France
State/province [45] 0 0
Amiens
Country [46] 0 0
France
State/province [46] 0 0
Angers
Country [47] 0 0
France
State/province [47] 0 0
Clermont-Ferrand
Country [48] 0 0
France
State/province [48] 0 0
Créteil
Country [49] 0 0
France
State/province [49] 0 0
Grenoble
Country [50] 0 0
France
State/province [50] 0 0
Lille
Country [51] 0 0
France
State/province [51] 0 0
Limoges
Country [52] 0 0
France
State/province [52] 0 0
Lyon
Country [53] 0 0
France
State/province [53] 0 0
Marseille
Country [54] 0 0
France
State/province [54] 0 0
Montpellier
Country [55] 0 0
France
State/province [55] 0 0
Nice
Country [56] 0 0
France
State/province [56] 0 0
Paris
Country [57] 0 0
France
State/province [57] 0 0
Pessac
Country [58] 0 0
France
State/province [58] 0 0
Strasbourg
Country [59] 0 0
France
State/province [59] 0 0
Toulouse
Country [60] 0 0
Germany
State/province [60] 0 0
Aachen
Country [61] 0 0
Germany
State/province [61] 0 0
Bonn
Country [62] 0 0
Germany
State/province [62] 0 0
Frankfurt am main
Country [63] 0 0
Germany
State/province [63] 0 0
Leipzig
Country [64] 0 0
Germany
State/province [64] 0 0
Mainz
Country [65] 0 0
Hong Kong
State/province [65] 0 0
Sha Tin
Country [66] 0 0
Hong Kong
State/province [66] 0 0
Tai Po
Country [67] 0 0
India
State/province [67] 0 0
Chandigarh
Country [68] 0 0
India
State/province [68] 0 0
Hyderabad
Country [69] 0 0
India
State/province [69] 0 0
Kolkata
Country [70] 0 0
India
State/province [70] 0 0
Ludhiana
Country [71] 0 0
India
State/province [71] 0 0
Mangalore
Country [72] 0 0
India
State/province [72] 0 0
Mumbai
Country [73] 0 0
India
State/province [73] 0 0
Nagpur
Country [74] 0 0
India
State/province [74] 0 0
New Delhi
Country [75] 0 0
Israel
State/province [75] 0 0
Afula
Country [76] 0 0
Israel
State/province [76] 0 0
Haifa
Country [77] 0 0
Israel
State/province [77] 0 0
Jerusalem
Country [78] 0 0
Israel
State/province [78] 0 0
Peta? Tiqwa
Country [79] 0 0
Israel
State/province [79] 0 0
Ramat Gan
Country [80] 0 0
Israel
State/province [80] 0 0
Tel Aviv
Country [81] 0 0
Italy
State/province [81] 0 0
Milan
Country [82] 0 0
Italy
State/province [82] 0 0
Rozzano
Country [83] 0 0
Japan
State/province [83] 0 0
Fukui
Country [84] 0 0
Japan
State/province [84] 0 0
Fukuoka
Country [85] 0 0
Japan
State/province [85] 0 0
Hiroshima
Country [86] 0 0
Japan
State/province [86] 0 0
Izunokuni
Country [87] 0 0
Japan
State/province [87] 0 0
Kanazawa
Country [88] 0 0
Japan
State/province [88] 0 0
Kashihara
Country [89] 0 0
Japan
State/province [89] 0 0
Kawasaki
Country [90] 0 0
Japan
State/province [90] 0 0
Kumamoto
Country [91] 0 0
Japan
State/province [91] 0 0
Kurume
Country [92] 0 0
Japan
State/province [92] 0 0
Kyoto
Country [93] 0 0
Japan
State/province [93] 0 0
Matsumoto
Country [94] 0 0
Japan
State/province [94] 0 0
Minato
Country [95] 0 0
Japan
State/province [95] 0 0
Miyazaki
Country [96] 0 0
Japan
State/province [96] 0 0
Nagakute
Country [97] 0 0
Japan
State/province [97] 0 0
Nara
Country [98] 0 0
Japan
State/province [98] 0 0
Okayama
Country [99] 0 0
Japan
State/province [99] 0 0
Osaka
Country [100] 0 0
Japan
State/province [100] 0 0
Saga
Country [101] 0 0
Japan
State/province [101] 0 0
Sapporo
Country [102] 0 0
Japan
State/province [102] 0 0
Shinjuku
Country [103] 0 0
Japan
State/province [103] 0 0
Suita
Country [104] 0 0
Japan
State/province [104] 0 0
Tsu
Country [105] 0 0
Japan
State/province [105] 0 0
Tono
Country [106] 0 0
Japan
State/province [106] 0 0
Yamagata
Country [107] 0 0
Japan
State/province [107] 0 0
Yokohama
Country [108] 0 0
Japan
State/province [108] 0 0
Omura
Country [109] 0 0
Korea, Republic of
State/province [109] 0 0
Daegu
Country [110] 0 0
Korea, Republic of
State/province [110] 0 0
Goyang-si
Country [111] 0 0
Korea, Republic of
State/province [111] 0 0
Incheon
Country [112] 0 0
Korea, Republic of
State/province [112] 0 0
Seongnam
Country [113] 0 0
Korea, Republic of
State/province [113] 0 0
Seoul
Country [114] 0 0
Mexico
State/province [114] 0 0
Mexico City
Country [115] 0 0
Mexico
State/province [115] 0 0
Monterrey
Country [116] 0 0
New Zealand
State/province [116] 0 0
Auckland
Country [117] 0 0
New Zealand
State/province [117] 0 0
Dunedin
Country [118] 0 0
Poland
State/province [118] 0 0
Bytom
Country [119] 0 0
Poland
State/province [119] 0 0
Myslowice
Country [120] 0 0
Poland
State/province [120] 0 0
Lódz
Country [121] 0 0
Puerto Rico
State/province [121] 0 0
San Juan
Country [122] 0 0
Singapore
State/province [122] 0 0
Singapore
Country [123] 0 0
Spain
State/province [123] 0 0
Alcorcón
Country [124] 0 0
Spain
State/province [124] 0 0
Barcelona
Country [125] 0 0
Spain
State/province [125] 0 0
Madrid
Country [126] 0 0
Spain
State/province [126] 0 0
Majadahonda
Country [127] 0 0
Spain
State/province [127] 0 0
Pontevedra
Country [128] 0 0
Spain
State/province [128] 0 0
Santander
Country [129] 0 0
Spain
State/province [129] 0 0
Sevilla
Country [130] 0 0
Spain
State/province [130] 0 0
Valencia
Country [131] 0 0
Switzerland
State/province [131] 0 0
Bern
Country [132] 0 0
Switzerland
State/province [132] 0 0
Lugano
Country [133] 0 0
Taiwan
State/province [133] 0 0
Kaohsiung
Country [134] 0 0
Taiwan
State/province [134] 0 0
Tainan
Country [135] 0 0
Taiwan
State/province [135] 0 0
Taipei
Country [136] 0 0
Taiwan
State/province [136] 0 0
Taoyuan
Country [137] 0 0
United Kingdom
State/province [137] 0 0
Glasgow
Country [138] 0 0
United Kingdom
State/province [138] 0 0
London
Country [139] 0 0
United Kingdom
State/province [139] 0 0
Nottingham
Country [140] 0 0
United Kingdom
State/province [140] 0 0
Plymouth
Country [141] 0 0
United Kingdom
State/province [141] 0 0
Portsmouth
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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)
When will data be available (start and end dates)?
18 months after study completion
Available to whom?
A secured external environment with username, password, and RSA code.
Available for what types of analyses?
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


What supporting documents are/will be available?




Results publications and other study-related documents



Results are available at https://clinicaltrials.gov/study/NCT03053063