Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
NCT ID: NCT02258581
Last Updated: 2017-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
241 participants
OBSERVATIONAL
2014-12-09
2017-08-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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GS-4774
Exposure of interest for participants who received GS-4774 (administered as a subcutaneous injection) in a previous Gilead study for chronic hepatitis B virus infection.
GS-9620
Exposure of interest for participants who received GS-9620 (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.
Tenofovir disoproxil fumarate (TDF)
Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures
* Must be willing and able to comply with the visit schedule and study requirements
* Must have documented HBV DNA \< 2,000 IU/mL at time of screening visit, which shall occur no later than 1 year post last study visit in GS-US-174-0149
* Must have documented hepatitis B surface antigen (HBsAg) negative status anytime during participation in GS-US-174-0149 regardless of ongoing HBV treatment
Exclusion Criteria
* History of clinically-significant illness or any other major medical disorder that may interfere with follow-up, assessments or compliance with the protocol
* Believed by the Study Investigator to be inappropriate for study participation for any reason not otherwise listed
* Received TDF monotherapy either as part of GS-US-174-0149 Arm C (TDF monotherapy arm) or for TDF retreatment, and have taken any HBV antiviral therapy since completion of GS-US-174-0149
18 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Kaiser Permanente
Sacramento, California, United States
Kaiser Permanente
San Diego, California, United States
Kaiser Permanente
San Francisco, California, United States
Silicon Valley Research Institute
San Jose, California, United States
University of Miami
Miami, Florida, United States
The Queen's Medical Center
Honolulu, Hawaii, United States
Northwestern University
Chicago, Illinois, United States
Digestive Disease Associates, PA
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Louis University
St Louis, Missouri, United States
Medical Procare, PLL
Flushing, New York, United States
Northwell Health
Manhasset, New York, United States
Xiaoli Ma, PC
Philadelphia, Pennsylvania, United States
Bon Secours St. Mary's Hospital of Richmond
Newport News, Virginia, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
University of Calgary
Calgary, Alberta, Canada
Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada
Liver and Intestinal Research Centre
Vancouver, British Columbia, Canada
University of Manitoba
Winnepeg, Manitoba, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Princess Margaret Hospital
Lai Chi Kok, , Hong Kong
Prince of Wales Hospital
Shatin, , Hong Kong
Nirmal Hospital Private Limited
Surat, Gurarat, India
Midas Multispecialty Hospital Private Limited
Nagpur, Maharashtra, India
Dept. of Hepatology, School of Digestive & Liver Diseases
Kolkata, West Bengal, India
IRCCS Ospedale Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera Universitaria Pisana
Caianello, Pisa, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria di Parma
Parma, , Italy
Auckland City Hospital
Auckland, , New Zealand
Pusan National
Busan, , South Korea
Korea University
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Bundang Hospital
Seoul, , South Korea
Yonsei University
Seoul, , South Korea
Countries
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Other Identifiers
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2015-001050-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-330-1508
Identifier Type: -
Identifier Source: org_study_id