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
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
Click here to add this to my saved trials
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
Click here to add this to my saved trials
Click here to add this to my saved trials
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
Click here to add this to my saved trials
Click here to add this to my saved trials
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
Click here to add this to my saved trials
Click here to add this to my saved trials
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Cincinnati The University of Cincinnati offers students a balance of educational excellence and...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Intermountain Medical Center Intermountain Medical Center is one of the most technologically advanced and patient-friendly...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Columbia University Medical Center Situated on a 20-acre campus in Northern Manhattan and accounting for...
Click here to add this to my saved trials
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
Click here to add this to my saved trials
Click here to add this to my saved trials
University of Pittsburgh Medical Center UPMC is one of the leading nonprofit health systems in...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
Click here to add this to my saved trials
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
Click here to add this to my saved trials
Stanford University Stanford University, located between San Francisco and San Jose in the heart of...
Click here to add this to my saved trials
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...
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials