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Trial record 8 of 150 for:    Cirrhosis | Non-Alcoholic Steatohepatitis

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

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: NCT01672879
Recruitment Status : Terminated
First Posted : August 27, 2012
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

The primary objective of 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)

Condition or disease Intervention/treatment Phase
Non-Alcoholic Steatohepatitis (NASH) Biological: Simtuzumab Biological: Placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 259 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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)
Actual Study Start Date : October 29, 2012
Actual Primary Completion Date : September 6, 2016
Actual Study Completion Date : January 3, 2017


Arm Intervention/treatment
Experimental: SIM 200 mg
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.
Biological: Simtuzumab
Intravenous infusion over 30 minutes every 2 weeks
Other Name: GS-6624

Experimental: SIM 700 mg
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.
Biological: Simtuzumab
Intravenous infusion over 30 minutes every 2 weeks
Other Name: GS-6624

Placebo Comparator: Placebo
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.
Biological: Placebo
Placebo to match simtuzumab intravenous infusion over 30 minutes every 2 weeks




Primary Outcome Measures :
  1. Mean change from baseline in hepatic venous pressure gradient (HVPG) [ Time Frame: Baseline to Week 96 ]
  2. 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


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01672879


  Hide Study Locations
Locations
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United States, Arizona
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
United States, California
Southern California Liver Centers
Coronado, California, United States, 92118
University of California, San Diego (UCSD)
San Diego, California, United States, 92103
University of California San Francisco (UCSF)
San Francisco, California, United States, 94143
United States, Colorado
University of Colorado, Denver
Aurora, Colorado, United States, 80045
United States, Florida
University of Miami
Miami, Florida, United States, 33136
Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University School of Medicine, Division of Gastroenterology/Hepatology
Indianapolis, Indiana, United States, 46202
United States, Iowa
Iowa Digestive Disease Center
Clive, Iowa, United States, 50325
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Louisiana
Tulane University
New Orleans, Louisiana, United States, 70112
United States, Maryland
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20889
United States, Massachusetts
Lahey Clinic
Burlington, Massachusetts, United States, 01805
United States, Michigan
University of Mississippi Medical Center
Jackson, Michigan, United States, 39216
United States, Minnesota
Minnnesota Gastroenterology, PA
Saint Paul, Minnesota, United States, 55114
United States, Missouri
Saint Louis University Hospital
Saint Louis, Missouri, United States, 63110
United States, New York
State University Of New York at Buffalo
Buffalo, New York, United States, 14203
North Shore University Health System
Manhasset, New York, United States, 11030
New York University
New York, New York, United States, 10016
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
United States, Ohio
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
University Gastroenterology
Providence, Rhode Island, United States, 02905
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Methodist University Hospital
Memphis, Tennessee, United States, 38104
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Brooke Army Medical Center
Fort Sam Houston, Texas, United States, 78234
St. Luke Episcopal Hospital
Houston, Texas, United States, 77030
Alamo Clinical Research Associates
San Antonio, Texas, United States, 78215
United States, Utah
Intermountain Transplant Center
Murray, Utah, United States, 84107
United States, Virginia
University of Virginia Health Center
Charlottesville, Virginia, United States, 22908
Liver Institute of Virginia
Newport News, Virginia, United States, 23602
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
Bucheon St. Marys Hospital
Richmond, Virginia, United States, 23226
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
University of Washington
Seattle, Washington, United States, 98104
Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada, R3E 3P4
Canada, Nova Scotia
Dalhousie University
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Toronto Liver Centre
Toronto, Ontario, Canada, M6H 3M1
France
Hôpital de la Croix Rousse
Lyon, France, 69317
Hospital Saint-Antoine
Paris, France, 75012
CHU Pitié-Salpêtrière
Paris, France, 75013
Fonds de Recherche Honoraires
Strasbourg, France, 67091
Germany
Gastroenterologisch-Hepatologisches Zentrum Kiel
Kiel, Germany, 24146
Eugastro Gmbh
Leipzig, Germany, 4129
Italy
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, Italy, 41100
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Torino, Italy, 10126
Puerto Rico
Fundacion De Investigacion
San Juan, Puerto Rico, 00927
Spain
Hospital Vall D´Hebron
Barcelona, Cataluna, Spain, 08035
Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, Spain, 28222
United Kingdom
Royal Free Hospital, Pond Street
London, United Kingdom, NW3 2QG
King's College Hospital NHS Trust
London, United Kingdom, SE5 9RS
Nottingham University Hospitals Queen's Medical Centre
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
Gilead Sciences
Investigators
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Study Director: Gilead Study Director Gilead Sciences

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01672879     History of Changes
Other Study ID Numbers: GS-US-321-0106
2012-002489-11 ( EudraCT Number )
First Posted: August 27, 2012    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
cirrhosis
Nonalcoholic Steatohepatitis
NASH
Compensated Liver disease
Monoclonal antibody
LOXL2
Simtuzumab
Hepatic venous pressure gradient
HVPG
NAFLD
MRE
Liver biopsy

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Fatty Liver
Non-alcoholic Fatty Liver Disease
Pathologic Processes
Liver Diseases
Digestive System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs