Hepatitis BPhase 1/2NCT01146808
Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver
A Phase 1/2 study testing Adefovir dipivoxil and hepatitis B vaccination in people with Hepatitis B and Liver Transplantation, run by Columbia University at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis B, Liver Transplantation
- What is being tested?
- Adefovir dipivoxil and hepatitis B vaccination
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Sep 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Recipients who do not have evidence of hepatitis B surface antigen, regardless of HBcAb and HBsAb status, who:
- received liver transplantation with hepatitis B core antibody positive (and HBsAg negative) grafts,
- received adefovir treatment post transplantation, and
- who have not reached the 18 month post transplantation time period.
Who cannot join
- Recipients with hepatitis B surface antigen positivity prior to liver transplant.
- Grafts from hepatitis B surface antigen positive patients.
- Previous intolerance to ADV therapy
- Recipients with pre-transplant creatinine > 1.6 mg/dL
- Patients younger than 21 years of age
- Patients who are pregnant or breastfeeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Liver Disease and Transplantation at Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Prevention of de Novo Hepatitis B Infection With Adefovir Dipivoxil (ADV) and Hepatitis B Vaccination in HBsAg Seronegative Recipients of Liver Grafts From Hepatitis B Core Antibody Positive (HBcAb+) Donors
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.
Read the detailed description
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.
- Conditions
- Hepatitis B, Liver Transplantation
- Being tested
- Adefovir dipivoxil and hepatitis B vaccination
- Keywords
- Vaccination, Immunocompromised Host, Antiviral Agents, Drug Resistance, Viral, Resource Allocation
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adefovir dipivoxil and hepatitis B vaccinationDrug
Also called Hepsera
Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Adefovir dipivoxil and hepatitis B vaccination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Standard of care visits post-transplant for 2 years
Secondary outcomes (2)
Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination
Measured: 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
Measured: Six months after hepatitis B vaccination (2 years post transplant)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startMar 2006
- Primary completionSep 2011
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Robert S Brown, Jr, MD, MPH, Principal investigator, Center for Liver Disease and Transplantation at Columbia University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146808
- Sponsor's protocol ID
- AAAB8413
- Other IDs
- IN-US-103-0158
- Status last verified
- Aug 2021
- First submitted
- 16 Jun 2010
- Last updated
- 10 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 7839446Saab 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.
PubMed 14526400
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of de Novo Hepatitis B Infection With Adefovir Dipivoxil (ADV) and Hepatitis B Vaccination in HBsAg Seronegative Recipients of Liver Grafts From Hepatitis B Core Antibody Positive (HBcAb+) Donors
- ClinicalTrials.gov ID
- NCT01146808
- Acronym / sponsor ID
- AAAB8413
- Conditions
- Hepatitis B, Liver Transplantation
- Keywords
- Vaccination, Immunocompromised Host, Antiviral Agents, Drug Resistance, Viral, Resource Allocation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Gilead Sciences
- Study start
- Mar 2006
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 15 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADV plus hepatitis B vaccination | Experimental | Drug: Adefovir dipivoxil and hepatitis B vaccinationAdefovir 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Recipients who do not have evidence of hepatitis B surface antigen, regardless of HBcAb and HBsAb status, who:
Key exclusion criteria (6 listed)
- Recipients with hepatitis B surface antigen positivity prior to liver transplant.
- Grafts from hepatitis B surface antigen positive patients.
- Previous intolerance to ADV therapy
- Recipients with pre-transplant creatinine > 1.6 mg/dL
- Patients younger than 21 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adefovir dipivoxil and hepatitis B vaccinationAlso: HepseraAdefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose | Drug | ADV plus hepatitis B vaccination |
Primary outcome
Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver
Time frame: Standard of care visits post-transplant for 2 years
Determined by positive hepatitis B serology (tests positive for HBsAg) and HBV DNA viral load (>40 IU/mL).
2 secondary outcomes
Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination
Time frame: 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
Time frame: Six months after hepatitis B vaccination (2 years post transplant)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 7839446Wachs 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.
- Background: PubMed 14526400Saab 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.
- Liver Transplantation information from the NIHLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Brown, Jr, MD, MPH principal investigator
Center for Liver Disease and Transplantation at Columbia University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Adefovir dipivoxil and hepatitis B vaccination in people with Hepatitis B and Liver Transplantation, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver (time frame: Standard of care visits post-transplant for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01146808, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2021.