Phase 2
N=16
Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver
Hepatitis B · Liver Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT01146808 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver — 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Adefovir dipivoxil and hepatitis B vaccination (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Columbia University
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Development of de Novo Hepatitis B Infection After Transplant With a Core Antibody Positive Liver |
5 | — |
| SECONDARY Proportion of Patients With a Sustained Hepatitis B Surface Antibody Titer > 500 IU/mL Prior to and After Vaccination |
2 | — |
| SECONDARY Proportion of Patients Who Develop de Novo Hepatitis B Infection Post ADV Withdrawal, Which Will be Assessed at 6 Months Post Withdrawal |
3 | — |
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). 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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01146808). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.