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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-001050-16 | EudraCT Number |
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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GS-4774 | Drug | 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 | Drug | 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) | Drug | Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with serum hepatitis B surface antigen (HBsAg) decline ≥ 0.5 log10 IU/ml from baseline at Week 48 | This endpoint will be measured for participants who are HBsAg positive at baseline. | Week 48 |
| Proportion of participants who remain HBsAg negative at Week 48 | This endpoint will be measured for participants who are HBsAg negative at baseline. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with serum HBsAg decline ≥ 0.5 log10 IU/ml from baseline at Week 144 | This endpoint will be measured for participants who are HBsAg positive at baseline. | Week 144 |
| Proportion of participants who achieve HBsAg loss at Weeks 48 and 144 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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Participants who were treated in a Gilead-sponsored trial for hepatitis B virus infection.
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| Name | Affiliation | Role |
|---|---|---|
| Gilead Study Director | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente | Sacramento | California | United States | |||
| Kaiser Permanente |
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Blood samples
This endpoint will be measured for participants who are HBsAg positive at baseline. |
| Weeks 48, 144 |
| Proportion of participants who remain HBsAg negative at Week 144 | This endpoint will be measured for participants who are HBsAg negative at baseline. | Week 144 |
| Proportions of participants with hepatitis B envelope antigen (HBeAg) loss and seroconversion at Week 48 | This endpoint will be measured for participants who are HBeAg positive at baseline. | Week 48 |
| Proportions of participants with HBeAg loss and seroconversion at Week 144 | This endpoint will be measured for participants who are HBeAg positive at baseline. | Week 144 |
| Proportions of participants who remain HBeAg negative and hepatitis B envelope antibody (HBeAb) positive at Week 48 | This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study. | Week 48 |
| Proportions of participants who remain HBeAg negative and HBeAb positive at Week 144 | This endpoint will be measured for HBeAg positive who achieved HBeAg seroconversion during the parental study. | Week 144 |
| Proportion of participants with HBV DNA < the lower limit of quantitation (LLOQ) at Weeks 48, 96 and 144 | This endpoint will be measured for participants who are on treatment with oral antiviral (OAV) anti-HBV. | Weeks 48, 96 and 144 |
| Change from Baseline in HBV DNA at Weeks 48, 96, and 144 | Baseline; Week 48; Week 96; Week 144 |
| 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 |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C582524 | vesatolimod |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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