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Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2017 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02854605
First received: July 29, 2016
Last updated: February 15, 2017
Last verified: February 2017

July 29, 2016
February 15, 2017
October 26, 2016
May 2018   (Final data collection date for primary outcome measure)
  • Overall Safety of GS-9674 as Assessed By Proportion of Participants Experiencing Treatment Emergent Adverse Events (AEs) [ Time Frame: Up to 24 weeks plus 30 days ]
  • Overall Safety of GS-9674 as Assessed By Proportion of Participants with Laboratory Abnormalities [ Time Frame: Up to 24 weeks plus 30 days ]
Same as current
Complete list of historical versions of study NCT02854605 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH)
A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Subjects With Nonalcoholic Steatohepatitis (NASH)
The primary objective of this study is to evaluate the safety and tolerability of GS-9674 in participants with nonalcoholic steatohepatitis (NASH).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Investigator
Primary Purpose: Treatment
Nonalcoholic Steatohepatitis (NASH)
  • Drug: GS-9674
    Tablet administered orally once daily
  • Drug: Placebo to match GS-9674
    Tablet(s) administered orally once daily
  • Experimental: GS-9674 30 mg
    GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
    Interventions:
    • Drug: GS-9674
    • Drug: Placebo to match GS-9674
  • Experimental: GS-9674 100 mg
    GS-9674 100 mg + placebo to match GS-9674 30 mg for 24 weeks
    Interventions:
    • Drug: GS-9674
    • Drug: Placebo to match GS-9674
  • Placebo Comparator: Placebo
    Placebo to match GS-9674 30 mg + placebo to match GS-9674 100 mg for 24 weeks
    Intervention: Drug: Placebo to match GS-9674
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
125
May 2018
May 2018   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • 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 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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
No
Contact: Gilead Study Team GS-US-402-1852@gilead.com
United States,   Canada
 
 
NCT02854605
GS-US-402-1852
2016-002496-10 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
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Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP