A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection



Status:Active, not recruiting
Conditions:Infectious Disease, Infectious Disease, Gastrointestinal, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:December 29, 2014
End Date:August 2023

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A Registry for Subjects With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection

This Registry will enroll cirrhotic participants with or without decompensated liver disease
who have achieved a sustained virologic response (SVR) after receiving a sofosbuvir
(SOF)-based regimen without interferon (IFN) while participating in a Gilead-sponsored
hepatitis C virus (HCV) study or commercially at selected sites. Once enrolled, participants
will be followed for up to 5 years.


Key Inclusion Criteria:

- Willing and able to provide written informed consent

- Have either previously participated in a Gilead-sponsored HCV study and received a
sofosbuvir-containing regimen without interferon OR at pre-selected sites only, have
received an all-oral SOF-based regimen outside a clinical study. These individuals
must have documentation of the regimen, start and end of treatment dates (month and
year), and of having achieved SVR12.

- Have achieved SVR either in a Gilead-sponsored study, as defined in the treatment
protocol OR for individuals who enroll after receiving an all-oral SOF-based regimen
outside a clinical study, SVR will be defined as HCV RNA < LLOQ approximately 12 weeks
following last dose of treatment.

- Have liver cirrhosis, as defined in the treatment protocol, and have not had a liver
transplant after receiving a SOF-containing regimen OR individuals who enroll after
receiving an all-oral SOF-based regimen outside a clinical study, will have had
cirrhosis confirmed prior to initiation of HCV treatment.

Key Exclusion Criteria:

- Individuals planning to initiate a new course of HCV therapy, including approved
products and any investigational agents, during the course of this Registry

- History of clinically-significant illness or any other major medical disorder that may
interfere with the follow-up, assessments, or compliance with the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
84
sites
Monroe, Louisiana 71201
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Birmingham, AL
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1000 Blythe Blvd
Charlotte, North Carolina 28203
(704) 355-2000
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Charlotte, NC
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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...
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Indianapolis, IN
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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Jacksonville, FL
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Los Angeles, CA
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1601 Northwest 12th Avenue
Miami, Florida 33136
(305) 243-6545
University of Miami Miller School of Medicine The University of Miami Leonard M. Miller School...
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Miami, FL
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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...
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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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Ann Arbor, Michigan 48109
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Annandale, Virginia
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1009 Magnolia Street
Arlington, Texas 76012
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Asheville, North Carolina 28801
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Atlanta, Georgia 30342
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Atlanta, Georgia 30312
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550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Aurora, Colorado 80045
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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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655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
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Binghamton, New York 13903
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Boston, Massachusetts
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Boston, Massachusetts 02215
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Camperdown, New South Wales 2050
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Camperdown,
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Catonsville, Maryland 21228
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303 East Superior Street
Chicago, Illinois 60611
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2600 Clifton Ave
Cincinnati, Ohio 45267
(513) 556-6000
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Coronado, California 92118
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Dallas, Texas 75246
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3310 Live Oak Street
Dallas, Texas 75204
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Detroit, Michigan 48202
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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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Fayetteville, North Carolina 28304
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Gainesville, Florida 32610
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Germantown, Tennessee 37138
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Hillsborough, New Jersey 08844
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Houston, Texas 77030
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Indianapolis, IN
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Kansas City, KS
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425 Volker Boulevard
Kansas City, Missouri 64131
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La Jolla, California 92037
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La Jolla, California 92093
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Live Oak, Texas 78233
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5901 East 7th Street
Long Beach, California 90822
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Los Angeles, California 90027
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1125 College Avenue
Los Angeles, California 76104
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601 North Broadway
Lutherville, Maryland 21205
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300 Community Drive
Manhasset, New York 11030
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Marietta, Georgia 30060
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Minneapolis, Minnesota 55455
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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...
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Nashville, Tennessee 37211
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New Orleans, Louisiana 70121
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630 W 168th St
New York, New York
212-305-2862
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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New York, New York 10021
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New York, New York 10021
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Newport News, Virginia 23602
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Norfolk, Virginia 23502
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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301 South Fair Oaks Avenue
Pasadena, California 91105
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Philadelphia, Pennsylvania 19104
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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130 South 9th Street
Philadelphia, Pennsylvania 19107
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200 Lothrop St
Pittsburgh, Pennsylvania 15213
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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Providence, Rhode Island 02905
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Rialto, California 92377
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Rochester, Minnesota 55905
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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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Saint Louis, Missouri 63110
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Saint Paul, Minnesota 55114
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San Antonio, Texas 78215
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San Diego, California 92123
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San Diego, California 92120
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San Francisco, California 94115
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505 Parnassus Ave
San Francisco, California 94143
(415) 476-1000
University of California, San Francisco Medical Center UCSF Medical Center is recognized throughout the world...
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Santa Fe, New Mexico 87505
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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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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450 Serra Mall
Stanford, California 94305
(650) 723-2300
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
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3800 Reservoir Rd NW
Washington, District of Columbia 20007
(202) 687-7695
Georgetown University Medical Center Georgetown University Medical Center is committed to excellence in research, education...
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Washington, District of Columbia 20009
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