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 |
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.
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
655 West Baltimore Street
Baltimore, Maryland 21201
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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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1601 Northwest 12th Avenue
Miami, Florida 33136
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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1211 Medical Center Dr
Nashville, Tennessee 37232
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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Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
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Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
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Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
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Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
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2315 Stockton Blvd.
Sacramento, California 95817
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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505 Parnassus Ave
San Francisco, California 94143
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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Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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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
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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