Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02466516
Recruitment Status : Completed
First Posted : June 9, 2015
Last Update Posted : February 27, 2017
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE June 5, 2015
First Posted Date  ICMJE June 9, 2015
Last Update Posted Date February 27, 2017
Study Start Date  ICMJE June 2015
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 5, 2015)
  • Adverse event profile of GS-4997 [ Time Frame: Up to 28 weeks ]
    Reported adverse events will include:
    • Incidence of treatment-emergent serious adverse events
    • Incidence of worsening of treatment-emergent liver laboratory abnormalities for alanine aminotransferase (ALT) and aspartate aminotransferase (AST), defined as at least 1 toxicity grade increase from baseline
  • Percentage of participants who prematurely discontinued study drug or study due to adverse events [ Time Frame: Up to 28 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02466516 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Adults With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
Official Title  ICMJE A Phase 2, Randomized, Open Label Study Evaluating the Safety, Tolerability, and Efficacy of GS-4997 Alone or in Combination With Simtuzumab (SIM) in Subjects With Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3
Brief Summary This study will evaluate the safety and tolerability of GS-4997 alone or in combination with Simtuzumab (SIM) in adults with Nonalcoholic Steatohepatitis (NASH) and Fibrosis Stages F2-F3. Participants will be randomized in a 2:2:1:1:1 ratio to 1 of 5 study treatment arms.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Non-Alcoholic Steatohepatitis (NASH)
Intervention  ICMJE
  • Drug: GS-4997
    GS-4997 tablets administered orally once daily
  • Biological: SIM
    Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
    Other Name: GS-6624
Study Arms  ICMJE
  • Experimental: GS-4997 6 mg
    GS-4997 6 mg for 24 weeks
    Intervention: Drug: GS-4997
  • Experimental: GS-4997 18 mg
    GS-4997 18 mg for 24 weeks
    Intervention: Drug: GS-4997
  • Experimental: GS-4997 6 mg+SIM 125 mg
    GS-4997 6 mg plus SIM 125 mg for 24 weeks
    Interventions:
    • Drug: GS-4997
    • Biological: SIM
  • Experimental: GS-4997 18 mg+SIM 125 mg
    GS-4997 18 mg plus SIM 125 mg for 24 weeks
    Interventions:
    • Drug: GS-4997
    • Biological: SIM
  • Experimental: SIM 125 mg
    SIM 125 mg for 24 weeks
    Intervention: Biological: SIM
Publications * Loomba R, Lawitz E, Mantry PS, Jayakumar S, Caldwell SH, Arnold H, Diehl AM, Djedjos CS, Han L, Myers RP, Subramanian GM, McHutchison JG, Goodman ZD, Afdhal NH, Charlton MR; GS-US-384-1497 Investigators. The ASK1 inhibitor selonsertib in patients with nonalcoholic steatohepatitis: A randomized, phase 2 trial. Hepatology. 2017 Sep 11. doi: 10.1002/hep.29514. [Epub ahead of print] Erratum in: Hepatology. 2018 May;67(5):2063.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 4, 2016)
72
Original Estimated Enrollment  ICMJE
 (submitted: June 5, 2015)
70
Actual Study Completion Date  ICMJE October 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Males and non-pregnant, non-lactating females
  • Evidence of NASH with fibrosis on biopsy

Key Exclusion Criteria:

  • Cirrhosis of the liver (e.g. Brunt/Kleiner score of F4)
  • Other causes of liver disease including viral hepatitis and alcoholic liver disease
  • Any history of decompensated liver disease, including ascites, hepatic encephalopathy or variceal bleeding
  • History of liver transplantation
  • Alcohol consumption greater than 21 oz/week for males or 14 oz/week for females (1 oz/30 mL of alcohol is present in 1 12 oz/360 mL beer, 1 4 oz/120 mL glass of wine, and a 1 oz/30 mL measure of 40% proof alcohol)

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02466516
Other Study ID Numbers  ICMJE GS-US-384-1497
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date November 2016

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