Long Term Follow-up Registry of Individuals Treated in A Gilead-Sponsored Trial in Individuals With Chronic Hepatitis B Infection
- Conditions
- Chronic Hepatitis B
- Registration Number
- NCT02258581
- Lead Sponsor
- Gilead Sciences
- Brief Summary
This study will evaluate the long term effects of hepatitis B virus (HBV) treatment on the HBV serologic changes and HBV DNA levels through Week 144. This registry will enroll only individuals who were treated in a Gilead-sponsored trial for chronic hepatitis B (CHB).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 241
- Must have participated in a Gilead-sponsored chronic hepatitis B (CHB) study no more than 120 days prior to Baseline (Day 1), except for participants from previous Gilead-sponsored study number GS-US-174-0149, who will have up to one year from their last visit in that protocol.
- 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
Key
- Patient participating or planning to participate in another clinical study with an investigational agent
- 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
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48 Week 48 This endpoint will be measured for participants who are HBsAg positive at baseline.
Proportion of participants who remain HBsAg negative at Week 48 Week 48 This endpoint will be measured for participants who are HBsAg negative at baseline.
- Secondary Outcome Measures
Name Time Method Proportion of participants who remain HBsAg negative at Week 144 Week 144 This endpoint will be measured for participants who are HBsAg negative at baseline.
Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48 Week 48 This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144 Week 144 This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study.
Change from Baseline in HBV DNA at Weeks 48, 96, and 144 Baseline; Week 48; Week 96; Week 144 Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144 Week 144 This endpoint will be measured for participants who are HBsAg positive at baseline.
Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144 Weeks 48, 96 and 144 This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV.
Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48 Week 48 This endpoint will be measured for participants who are HBeAg positive at baseline.
Proportion of participants who achieve HBsAg loss at Weeks 48 and 144 Weeks 48, 144 This endpoint will be measured for participants who are HBsAg positive at baseline.
Proportions of participants with HBeAg loss and seroconversion at Week 144 Week 144 This endpoint will be measured for participants who are HBeAg positive at baseline.
Trial Locations
- Locations (35)
IRCCS Ospedale Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, Foggia, Italy
Liver and Intestinal Research Centre
🇨🇦Vancouver, British Columbia, Canada
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Dept. of Hepatology, School of Digestive & Liver Diseases
🇮🇳Kolkata, West Bengal, India
Azienda Ospedaliera Universitaria di Parma
🇮🇹Parma, Italy
Northwestern University
🇺🇸Chicago, Illinois, United States
Midas Multispecialty Hospital Private Limited
🇮🇳Nagpur, Maharashtra, India
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Digestive Disease Associates, PA
🇺🇸Baltimore, Maryland, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, United States
Xiaoli Ma, PC
🇺🇸Philadelphia, Pennsylvania, United States
Yonsei University
🇰🇷Seoul, Korea, Republic of
University of Calgary
🇨🇦Calgary, Alberta, Canada
Kaiser Permanente
🇺🇸San Francisco, California, United States
University of Miami
🇺🇸Miami, Florida, United States
Northwell Health
🇺🇸Manhasset, New York, United States
Bon Secours St. Mary's Hospital of Richmond
🇺🇸Newport News, Virginia, United States
Medical Procare, PLL
🇺🇸Flushing, New York, United States
Pusan National
🇰🇷Busan, Korea, Republic of
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
Azienda Ospedaliera Universitaria Pisana
🇮🇹Caianello, Pisa, Italy
Korea University
🇰🇷Seoul, Korea, Republic of
Silicon Valley Research Institute
🇺🇸San Jose, California, United States
St. Louis University
🇺🇸Saint Louis, Missouri, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Princess Margaret Hospital
🇭🇰Lai Chi Kok, Hong Kong
Nirmal Hospital Private Limited
🇮🇳Surat, Gurarat, India
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
Seoul National University Bundang Hospital
🇰🇷Seoul, Korea, Republic of
Auckland City Hospital
🇳🇿Auckland, New Zealand
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Gordon and Leslie Diamond Health Care Centre
🇨🇦Vancouver, British Columbia, Canada
University of Manitoba
🇨🇦Winnepeg, Manitoba, Canada
Prince of Wales Hospital
🇭🇰Sha Tin, Hong Kong