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



Status:Terminated
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 65
Updated:5/6/2018
Start Date:October 29, 2012
End Date:January 3, 2017

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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)

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)


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.
We found this trial at
42
sites
3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
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Miami, Florida 33124
(305) 284-2211
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
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1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Arlington, Texas 76012
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
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Buffalo, New York 14222
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41 Mall Road
Burlington, Massachusetts 1805
781-744-5100
Lahey Clinic When Frank Lahey, MD, founded a group practice in 1923, his vision was...
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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Charlottesville, Virginia 22903
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303 East Superior Street
Chicago, Illinois 60611
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Clive, Iowa 50325
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Coronado, California 92118
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2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Houston, Texas 77030
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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Manhasset, New York 11030
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Memphis, Tennessee 38104
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Murray, Utah 84107
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New Orleans, Louisiana 70112
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70 Washington Square S
New York, New York 10012
(212) 998-1212
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630 W 168th St
New York, New York
212-305-2862
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Newport News, Virginia 23602
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Norfolk, Virginia 23502
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Philadelphia, Pennsylvania 19104
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Providence, Rhode Island 02905
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Richmond, Virginia 23603
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Richmond, Virginia 23298
(804) 828-0100
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
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3635 Vista at Grand Ave.
Saint Louis, Missouri 63110
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Saint Paul, Minnesota 55114
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San Antonio, Texas 78212
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San Diego, California 92103
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500 Parnassus Ave
San Francisco, California 94143
(415) 476-9000
University of California at San Francisco (UCSF) The leading university exclusively focused on health, UC...
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Winnipeg, Manitoba
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