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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02854605




Registration number
NCT02854605
Ethics application status
Date submitted
29/07/2016
Date registered
3/08/2016
Date last updated
29/01/2019

Titles & IDs
Public title
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
Scientific title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)
Secondary ID [1] 0 0
2016-002496-10
Secondary ID [2] 0 0
GS-US-402-1852
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Nonalcoholic Steatohepatitis (NASH) 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 - GS-9674
Treatment: Drugs - Placebo to match GS-9674

Experimental: GS-9674 30 mg - GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks

Experimental: GS-9674 100 mg - GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks

Placebo Comparator: Placebo - Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks


Treatment: Drugs: GS-9674
Tablet administered orally once daily

Treatment: Drugs: Placebo to match GS-9674
Tablet(s) administered orally once daily

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall Safety of GS-9674 as Assessed By Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) - TEAEs were defined as 1 or both of the following: 1) Any adverse events (AE) with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug, 2) Any AEs leading to premature discontinuation of study drug.
Timepoint [1] 0 0
Up to 24 weeks plus 30 days
Primary outcome [2] 0 0
Overall Safety of GS-9674 as Assessed By Percentage of Participants With Treatment-Emergent Laboratory Abnormalities - Treatment-emergent laboratory abnormalities are defined as values that increase at least 1 toxicity grade from baseline at any post-baseline time point, up to and including the date of last dose of study drug plus 30 days for participants who permanently discontinued study.
Timepoint [2] 0 0
Up to 24 weeks plus 30 days

Eligibility
Key inclusion criteria
Key

- Meets the following conditions:

- A clinical diagnosis of nonalcoholic fatty liver disease (NAFLD)

- Screening magnetic resonance imaging - proton density fat fraction (MRI-PDFF)
with = 8% steatosis

- Screening magnetic resonance elastography (MRE) with liver stiffness = 2.5
kilopascal (kPa) OR

- A historical liver biopsy within 12 months of screening consistent with NASH with
fibrosis, but not cirrhosis, and

- No documented weight loss > 5% between the date of the liver biopsy and
screening.

- Platelet count = 150,000/mm^3

- Albumin = 3.3 g/dL

- Serum creatinine = upper limit of normal (ULN)

Key
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or lactating females

- Alanine aminotransferase (ALT) > 5x upper limit of the normal range (ULN)

- Other causes of liver disease including autoimmune, viral, and alcoholic liver disease

- Cirrhosis of the liver

- Prior history of decompensated liver disease, including ascites, hepatic
encephalopathy, or variceal bleeding

- Body mass index (BMI) < 18 kg/m^2

- Uncontrolled diabetes mellitus (hemoglobin A1c > 9% at screening)

- International normalized ratio (INR) > 1.2 unless on anticoagulant therapy

- Total bilirubin > 1 x ULN, except with diagnosis of Gilbert's syndrome

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 analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Illinois
Country [5] 0 0
United States of America
State/province [5] 0 0
Louisiana
Country [6] 0 0
United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
State/province [7] 0 0
New York
Country [8] 0 0
United States of America
State/province [8] 0 0
North Carolina
Country [9] 0 0
United States of America
State/province [9] 0 0
Pennsylvania
Country [10] 0 0
United States of America
State/province [10] 0 0
Tennessee
Country [11] 0 0
United States of America
State/province [11] 0 0
Texas
Country [12] 0 0
United States of America
State/province [12] 0 0
Utah
Country [13] 0 0
United States of America
State/province [13] 0 0
Virginia
Country [14] 0 0
United States of America
State/province [14] 0 0
Washington
Country [15] 0 0
Canada
State/province [15] 0 0
Alberta
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Hong Kong
State/province [17] 0 0
Kowloon
Country [18] 0 0
Hong Kong
State/province [18] 0 0
Sha Tin
Country [19] 0 0
New Zealand
State/province [19] 0 0
Auckland
Country [20] 0 0
Switzerland
State/province [20] 0 0
Bern
Country [21] 0 0
Switzerland
State/province [21] 0 0
Zurich
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Cambridge

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 the safety and tolerability of GS-9674 in
participants with nonalcoholic steatohepatitis (NASH).
Trial website
https://clinicaltrials.gov/show/NCT02854605
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
Other publications