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Simtuzumab (GS-6624) in the Treatment of Cirrhosis Due to NASH (NASH)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01672879
First received: August 22, 2012
Last updated: February 23, 2017
Last verified: January 2017

August 22, 2012
February 23, 2017
October 29, 2012
July 28, 2016   (Final data collection date for primary outcome measure)
  • Mean change from baseline in hepatic venous pressure gradient (HVPG) [ Time Frame: Baseline to Week 96 ]
  • Event free survival [ Time Frame: Up to 240 weeks ]

    Event free survival (EFS) will be assessed by time to first liver-related event or death, whichever occurs first. Liver-related events include any of the following:

    • Liver transplantation
    • Qualification for liver transplantation

      -- Model for End-Stage Liver Disease (MELD) ≥ 15

    • Events indicative of hepatic decompensation

      • Esophageal variceal bleeding
      • Ascites
      • Hepatic Encephalopathy
      • ≥ 2 point increase in Child Pugh-Turcotte (CPT) score
      • Newly diagnosed varices in a subject without prior varices
Reverse cirrhosis in subjects with cirrhosis due to NASH by using GS-6624 [ Time Frame: Baseline to Week 100 ]
The subjects will receive intravenous (IV) infusions of blinded study drug every 2 weeks for 96 weeks.Regression of fibrosis as assessed by change from baseline in morphometric quantitative collagen on liver biopsy.
Complete list of historical versions of study NCT01672879 on ClinicalTrials.gov Archive Site
Safety data including adverse events, extent of exposure, laboratory evaluations, and immunogenicity [ Time Frame: Baseline to Week 96 plus 30 days ]
Safety data collected will be summarized by treatment arm.
Assess the safety of GS-6624 in subjects with compensated cirrhosis due to NASH [ Time Frame: Baseline through Week 100 ]
Subjects will be assessed throughout the trial for safety and tolerability.
Not Provided
Not Provided
 
Simtuzumab (GS-6624) in the Treatment of Cirrhosis Due to NASH
A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects With Compensated Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

This study is to evaluate the safety and efficacy of simtuzumab (GS-6624) in adults with compensated cirrhosis due to Non-Alcoholic Steatohepatitis (NASH). It will consist of 2 phases:

  • Randomized Double-Blind Phase
  • Open Label Phase (optional)
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Non-Alcoholic Steatohepatitis (NASH)
  • Biological: Simtuzumab
    Simtuzumab administered by intravenous infusion over 30 minutes every 2 weeks
    Other Name: GS-6624
  • Biological: Placebo
    Placebo to match simtuzumab administered by intravenous infusion over 30 minutes every 2 weeks
  • Experimental: Treatment Arm A
    Participants will receive simtuzumab 700 mg for up to 240 weeks during the Randomized Phase. During the optional Open Label Phase, participants will receive simtuzumab 700 mg for up to an additional 240 weeks.
    Intervention: Biological: Simtuzumab
  • Experimental: Treatment Arm B
    Participants will receive simtuzumab 200 mg for up to 240 weeks during the Randomized Phase. During the optional Open Label Phase, participants will receive simtuzumab 700 mg for up to an additional 240 weeks.
    Intervention: Biological: Simtuzumab
  • Placebo Comparator: Treatment Arm C
    Participants will receive placebo to match simtuzumab for up to 240 weeks during the Randomized Phase. During the optional Open Label Phase, participants will receive simtuzumab 700 mg for up to an additional 240 weeks.
    Intervention: Biological: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
259
January 3, 2017
July 28, 2016   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Adult subjects (aged 18-65) with cirrhosis of the liver defined as an Ishak fibrosis stage ≥ 5
  • Liver biopsy consistent with NASH or cryptogenic cirrhosis
  • Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease
  • Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x the upper limit of the normal range (ULN)
  • Must have serum creatinine < 2.0 mg/dL
  • A negative serum pregnancy test is required for female subjects of childbearing potential
  • All sexually active female subjects of childbearing potential must agree to use a protocol recommended method of contraception during heterosexual intercourse throughout the study and for 90 days following the last dose of study medication
  • Lactating females must agree to discontinue nursing before starting study treatment
  • Male subjects, if not vasectomized, are required to use barrier contraception (condom plus spermicide) during heterosexual intercourse from the screening through the study completion and for 90 days following the last dose of study drug

Key Exclusion Criteria:

  • Pregnant or breast feeding
  • Any history of hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding
  • Weight reduction surgery in the past 5 years
  • Positive for hepatitis C virus (HCV) RNA
  • Positive for HBsAg
  • Alcohol consumption greater than 21oz/week for males or 14oz/week for females
  • Positive urine screen for amphetamines, cocaine or opiates (i.e. heroin, morphine) at screening. Subjects on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to screening may be included in the study. Subjects with a positive urine drug screen due to prescription opioid-based medication are eligible if the prescription and diagnosis are reviewed and approved by the investigator
  • Clinically significant cardiac disease
  • History of malignancy, other than non-melanomatous skin cancer, within 5 years prior to screening
  • Major surgical procedure within 30 days prior to screening or the presence of an open wound
  • Known hypersensitivity to the investigation product or any of its formulation excipients
  • History of bleeding diathesis within 6 months of screening
  • Unavailable for follow-up assessment or concern for subject's compliance with the protocol procedures;
  • Participation in an investigational trial of a drug or device within 30 days prior to screening

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

Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   France,   Germany,   Italy,   Puerto Rico,   Spain,   United Kingdom
 
 
NCT01672879
GS-US-321-0106
2012-002489-11 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
January 2017

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