Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Subjects With Primary Sclerosing Cholangitis (PSC)



Status:Completed
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 70
Updated:2/25/2017
Start Date:February 2013
End Date:August 2016

Use our guide to learn which trials are right for you!

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 Primary Sclerosing Cholangitis (PSC)

The purpose of this study is to evaluate whether Simtuzumab (GS-6624) is effective at
preventing the progression of liver fibrosis in subjects with PSC.


Inclusion Criteria:

- Adult subjects (aged 18-70) with chronic cholestatic liver disease of at least 6
months.

- Liver biopsy consistent with PSC: If a liver biopsy has been performed within 3
months of the screening visit, tissue from that biopsy may be used as the screening
biopsy. Slides would be re-cut from the existing tissue block and submitted for
central reader assessment. Some subjects with PSC may have a normal liver biopsy, in
the event of a normal liver biopsy, the subject must have an abnormal magnetic
resonance cholangiopancreatography (MRCP).

- MRCP consistent with PSC: Some subjects with PSC may have a normal MRCP; in the event
of a normal MRCP, the subject must have an abnormal liver biopsy.

- Exclusion of other causes of liver disease including viral hepatitis ,alcoholic liver
disease,primary biliary cirrhosis and secondary sclerosing cholangitis

- Must have aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 10 x
the Central Laboratory Upper Limit of Normal (clULN)

- 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 intercourse from the screening through the study completion
and for 90 days following the last dose of study drug

Exclusion Criteria:

- Pregnant or breast feeding

- Evidence of hepatic decompensation present, including ascites, episodes of hepatic
encephalopathy, variceal bleeding or a prolonged prothrombin time/international
normalized ratio (PT/INR)

- Positive for hepatitis C virus (HCV) RNA

- Positive for HBsAg

- Positive for anti-mitochondrial antibody

- Alcohol consumption greater than 21oz/week for males or 14oz/week for females

- Moderately active ulcerative colitis (UC) defined as either a partial Mayo score of >
4, bleeding score of >1, or current use of oral corticosteroid therapy and/or any
inhibitor of Tumor necrosis factor-α (TNF-α) or α4β7 integrin antagonist

- 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 cholangiocarcinoma

- History of other cancers,other than non-melanomatous skin cancer, within 5 years
prior to screening

- Ascending cholangitis within 60 days of screening

- Presence of a percutaneous drain or bile duct stent

- 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

- Major surgical procedure within 30 days prior to screening or the presence of an open
wound
We found this trial at
44
sites
2201 Inwood Rd
Dallas, Texas 75235
(214) 645-8300
U.T. Southwestern Medical Center The story of UT Southwestern Medical Center is one of commitment...
?
mi
from
Dallas, TX
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
?
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
?
mi
from
Boston, MA
Click here to add this to my saved trials
9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
3551 Roger Brooke Dr
Fort Sam Houston, Texas 78234
(210) 916-4141
Brooke Army Medical Center Brooke Army Medical Center (BAMC) is the Flagship of Army Medicine!...
?
mi
from
Fort Sam Houston, TX
Click here to add this to my saved trials
425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
?
mi
from
Nashville, TN
Click here to add this to my saved trials
Sacramento, California 95814
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
University of Utah Research is a major component in the life of the U benefiting...
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
Seattle, Washington 98104
(206) 543-2100
Univ of Washington Founded in 1861 by a private gift of 10 acres in what...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
?
mi
from
Aurora, CO
Click here to add this to my saved trials
8901 Rockville Pike
Bethesda, Maryland 20889
(301) 295-4000
Walter Reed National Military Medical Center The Walter Reed National Military Medical Center is one...
?
mi
from
Bethesda, MD
Click here to add this to my saved trials
Brussels, 1070
?
mi
from
Brussels,
Click here to add this to my saved trials
Charlottesville, Virginia 22903
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
?
mi
from
Chicago, IL
Click here to add this to my saved trials
Chula Vista, California 91910
?
mi
from
Chula Vista, CA
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Clive, Iowa 50325
?
mi
from
Clive, IA
Click here to add this to my saved trials
Coronado, California 92118
?
mi
from
Coronado, CA
Click here to add this to my saved trials
Durham, North Carolina 27715
?
mi
from
Durham, NC
Click here to add this to my saved trials
Houston, Texas 77030
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
10666 N Torrey Pines Rd
La Jolla, California 92037
(858) 554-9100
Scripps Clinic Scripps Clinic in Torrey Pines has been providing exceptional medical care to people...
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
500 S Preston St
Louisville, Kentucky
(502) 852-5555
University of Louisville The University of Louisville is a state supported research university located in...
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
5121 S Cottonwood St
Murray, Utah 84157
(801) 507-7000
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
?
mi
from
Murray, UT
Click here to add this to my saved trials
1430 Tulane Ave Suite SL32
New Orleans, Louisiana 70112
(504) 588-5912
Tulane University Health Sciences Center One of the nation's most recognized centers for medical education,...
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
New York, New York 10029
?
mi
from
New York, NY
Click here to add this to my saved trials
Newport News, Virginia 23602
?
mi
from
Newport News, VA
Click here to add this to my saved trials
Norfolk, Virginia 23502
?
mi
from
Norfolk, VA
Click here to add this to my saved trials
Palo Alto, California 94304
?
mi
from
Palo Alto, CA
Click here to add this to my saved trials
3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
Univ of Pennsylvania Penn has a long and proud tradition of intellectual rigor and pursuit...
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Providence, Rhode Island 02905
?
mi
from
Providence, RI
Click here to add this to my saved trials
Richmond, Virginia 23226
?
mi
from
Richmond, VA
Click here to add this to my saved trials
?
mi
from
Richmond, VA
Click here to add this to my saved trials
San Antonio, Texas 78215
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94143
?
mi
from
San Francisco, CA
Click here to add this to my saved trials
Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
?
mi
from
Seattle, WA
Click here to add this to my saved trials
3635 Vista at Grand Ave.
St. Louis, Missouri 63220
?
mi
from
St. Louis, MO
Click here to add this to my saved trials
St. Paul, Minnesota 55114
?
mi
from
St. Paul, MN
Click here to add this to my saved trials
1295 North Martin Avenue
Tucson, Arizona 85721
(520) 626-1197
University of Arizona Health Sciences Center The Arizona Health Sciences Center (AHSC) at the University...
?
mi
from
Tucson, AZ
Click here to add this to my saved trials