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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)
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
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United States of America
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Arkansas
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Plymouth
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Portsmouth
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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 not provided in https://clinicaltrials.gov/study/NCT03053063