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| ID | Type | Description | Link |
|---|---|---|---|
| IN-US-103-0158 | Other Identifier | Gilead |
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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface antigen (HBsAg) positive prior to transplant (Hepatitis B naive patients). The second objective is to evaluate the efficacy of accelerated vaccination with Hepatitis B in inducing innate immunity, thereby obviating the need for life-long antiviral therapy.
The investigators will conduct a prospective, open-label study of Hepatitis B naive patients who received HBcAb + livers and adefovir prophylaxis post-transplant. At one year to 18 months following transplantation, all study patients will then be vaccinated with standard Hepatitis B vaccine at double dose on a monthly basis for three months, at which point they will be tested for Hepatitis B surface antibody (HBsAb). Any study patients that have developed a sufficient antibody response (HBsAb >500 IU) will be given the option to discontinue anti-viral treatment in a monitored setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ADV plus hepatitis B vaccination | Experimental | Adefovir dipivoxil and hepatitis B vaccination: All subjects will receive adefovir 10mg po daily, or adjusted for renal function and an option for Hepatitis B vaccination, double dose. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adefovir dipivoxil and hepatitis B vaccination | Drug | Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver | Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (>40 IU/mL). | Standard of care visits post-transplant for 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination | 12-18 months post transplant | |
| Proportion of Patients Who Develop de Novo Hepatitis B Infection Post ADV Withdrawal, Which Will be Assessed at 6 Months Post Withdrawal |
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Inclusion Criteria:
Recipients who do not have evidence of hepatitis B surface antigen, regardless of HBcAb and HBsAb status, who:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Brown, Jr, MD, MPH | Center for Liver Disease and Transplantation at Columbia University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Liver Disease and Transplantation at Columbia University Medical Center | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7839446 | Background | Wachs ME, Amend WJ, Ascher NL, Bretan PN, Emond J, Lake JR, Melzer JS, Roberts JP, Tomlanovich SJ, Vincenti F, et al. The risk of transmission of hepatitis B from HBsAg(-), HBcAb(+), HBIgM(-) organ donors. Transplantation. 1995 Jan 27;59(2):230-4. | |
| 14526400 | Background | Saab S, Chang AJ, Comulada S, Geevarghese SK, Anselmo RD, Durazo F, Han S, Farmer DG, Yersiz H, Goldstein LI, Ghobrial RM, Busuttil RW. Outcomes of hepatitis C- and hepatitis B core antibody-positive grafts in orthotopic liver transplantation. Liver Transpl. 2003 Oct;9(10):1053-61. doi: 10.1053/jlts.2003.50208. |
| Label | URL |
|---|---|
| Liver Transplantation information from the NIH | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | ADV Plus Hepatitis B Vaccination Group | This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ADV Plus Hepatitis B Vaccination Group | This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver | Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (>40 IU/mL). | Posted | Count of Participants | Participants | Standard of care visits post-transplant for 2 years |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ADV Plus Hepatitis B Vaccination Group | This group included recipients of Hepatitis B Core Antibody Positive livers who are negative for Hepatitis B infection. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert S. Brown Jr., MD, MPH | Columbia University Medical Center | (212) 305-3839 | tt2103@columbia.edu |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C106812 | adefovir dipivoxil |
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|
| Six months after hepatitis B vaccination (2 years post transplant) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
|
| Secondary | Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination | Posted | Count of Participants | Participants | 12-18 months post transplant |
|
|
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| Secondary | Proportion of Patients Who Develop de Novo Hepatitis B Infection Post ADV Withdrawal, Which Will be Assessed at 6 Months Post Withdrawal | Posted | Count of Participants | Participants | Six months after hepatitis B vaccination (2 years post transplant) |
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| 0 |
| 16 |
| 0 |
| 16 |
| 0 |
| 16 |
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| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |