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

NCT01146808 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: AAAB8413IN-US-103-0158
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B; Liver Transplantation

Keywords

Vaccination; Immunocompromised Host; Antiviral Agents; Drug Resistance, Viral; Resource Allocation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• 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

  Six months after hepatitis B vaccination (2 years post transplant)

Study Arms (1)

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.

Drug: Adefovir dipivoxil and hepatitis B vaccination

Interventions

Adefovir dipivoxil and hepatitis B vaccination DRUG

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

Also known as: Hepsera

ADV plus hepatitis B vaccination

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Gilead Sciences: collaborator

Study Sites (1)

Center for Liver Disease and Transplantation at Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Publications (2)

• 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.

  PMID: 7839446 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.

  PMID: 14526400 BACKGROUND

Related Links

• Liver Transplantation information from the NIH

MeSH Terms

Conditions

Hepatitis B

Interventions

adefovir dipivoxil

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Robert S. Brown Jr., MD, MPH
• Organization: Columbia University Medical Center

tt2103@columbia.edu

(212) 305-3839

Study Officials

• Robert S Brown, Jr, MD, MPH

  Center for Liver Disease and Transplantation at Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 22, 2010
• Study Start: March 1, 2006
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2012
• Last Updated: August 10, 2021
• Results First Posted: March 15, 2017

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)