Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver

NCT ID: NCT01146808

Last Updated: 2021-08-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-03-31
• Study Completion Date: 2012-09-30

Brief 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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ADV plus hepatitis B vaccination

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.

Group Type: EXPERIMENTAL

Adefovir dipivoxil and hepatitis B vaccination

Intervention Type: DRUG

Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose

Interventions

Adefovir dipivoxil and hepatitis B vaccination

Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose

Intervention Type: DRUG

Other Intervention Names

Hepsera

Eligibility Criteria

Inclusion Criteria

• Recipients who do not have evidence of hepatitis B surface antigen, regardless of HBcAb and HBsAb status, who:

1. received liver transplantation with hepatitis B core antibody positive (and HBsAg negative) grafts,

2. received adefovir treatment post transplantation, and

3. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert S Brown, Jr, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Center for Liver Disease and Transplantation at Columbia University Medical Center

Locations

Center for Liver Disease and Transplantation at Columbia University Medical Center

New York, New York, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 7839446 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14526400 (View on PubMed)

Related Links

http://www.nlm.nih.gov/medlineplus/livertransplantation.html

Liver Transplantation information from the NIH

Other Identifiers

IN-US-103-0158

Identifier Type: OTHER

Identifier Source: secondary_id

AAAB8413

Identifier Type: -

Identifier Source: org_study_id