A Phase 2 Study to See if Simtuzumab (GS-6624) is Safe and Works in Idiopathic Pulmonary Fibrosis (IPF)



Status:Terminated
Conditions:Pulmonary
Therapuetic Areas:Pulmonary / Respiratory Diseases
Healthy:No
Age Range:45 - 85
Updated:4/21/2016
Start Date:January 2013
End Date:February 2016

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A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) in adults with
idiopathic pulmonary fibrosis.


Inclusion Criteria:

- Male or female subjects from 45 to 85 years of age

- Definite IPF within 3 years prior to screening

- Be able to walk at least 50 meters

Exclusion Criteria:

- Significant diseases other than IPF

- Obstructive lung disease

- Aortic aneurysm greater than or equal to 3.5 cm in diameter

- Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to
randomization are not permitted.

- N-acetylcysteine is permitted provided the individual has been on a stable dose
for > 4 weeks prior to screening

- Concomitant use of pirfenidone or nintedanib must be in accordance with the
approved prescribing instructions in the country where the site is located

- Individuals actively listed for lung transplant are excluded. However individuals at
transplant centers with long waiting times (greater than 1 year) may be permitted to
enter the study after discussion with Medical Monitor.
We found this trial at
73
sites
300 Pasteur Dr
Stanford, California 94305
(650) 723-4000
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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75 Francis street
Boston, Massachusetts 02115
(617) 732-5500
Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
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616 E Street
Clearwater, Florida 33756
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
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3300 Gallows Road
Falls Church, Virginia 22042
(703) 776-4001
Inova Fairfax Hospital Inova Fairfax Hospital, Inova's flagship hospital, is an 833-bed, nationally recognized regional...
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
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116th St and Broadway
New York, New York 10027
(212) 854-1754
Columbia University In 1897, the university moved from Forty-ninth Street and Madison Avenue, where it...
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201 Presidents Circle
Salt Lake City, Utah 84108
801) 581-7200
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Seattle, Washington 98104
(206) 543-2100
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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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2950 Cleveland Clinic Blvd.
Weston, Florida 33331
866.293.7866
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47 New Scotland Ave
Albany, New York 12208
(518) 262-3125
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1364 Clifton Rd NE
Atlanta, Georgia 30322
(404) 712-2000
Emory University Hospital As the largest health care system in Georgia and the only health...
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Baltimore, Maryland 20742
(301) 405-1000
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Boston, Massachusetts 02111
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Camperdown, New South Wales 2050
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Chesterfield, Missouri 63017
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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303 East Superior Street
Chicago, Illinois 60611
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Council Bluffs, Iowa 51503
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Decatur, Georgia 30033
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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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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Everett, Washington 98201
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200 Hawkins Dr,
Iowa City, Iowa 52242
866-452-8507
University of Iowa Hospitals and Clinics University of Iowa Hospitals and Clinics—recognized as one of...
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Jacksonville, Florida 32209
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
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Jamaica, New York 11418
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Kansas City, Missouri 64111
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9500 Gilman Dr
La Jolla, California 92093
(858) 534-2230
The University of California, San Diego UC San Diego is an academic powerhouse and economic...
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1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
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Louisville, Kentucky 40202
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500 S Preston St
Louisville, Kentucky
(502) 852-5555
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2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
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Minneapolis, Minnesota 55455
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New Brunswick, New Jersey 08901
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333 Cedar St
New Haven, Connecticut 06504
(203) 432-4771
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New Hyde Park, New York 11042
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New Orleans, Louisiana 70112
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New York, New York 10029
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Philadelphia, Pennsylvania 19140
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
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3451 Walnut St
Philadelphia, Pennsylvania 19104
1 (215) 898-5000
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Phoenix, Arizona 85013
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Portland, Oregon 97210
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Rochester, Minnesota 55905
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Rochester, New York 14620
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2315 Stockton Blvd.
Sacramento, California 95817
(916) 734-2011
University of California, Davis Medical Center UC Davis Medical Center serves a 65,000-square-mile area that...
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
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San Francisco, California 94143
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Santa Barbara, California 93105
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1700 S Tamiami Trail
Sarasota, Florida 34239
(941) 917-9000
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Scottsdale, Arizona 85258
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
480-301-8000
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Summit, New Jersey 07901
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Tucson, Arizona 85721
(520) 621-2211
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