Detecting Occult HBV Infection in Liver Donors Positive for Antibody to Hepatitis B Core Antigen (Anti-HBc)

NCT04199819 | Unknown

• 1 other identifier: occult HBV infection 01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

After LT, long-term immunosuppressive therapy is required to prevent organ rejection. Therefore, for organs which may harbour OBI, there is a risk of reactivation which may result in liver graft failure. As a consequence, all patients who receive an anti-HBc positive graft will receive antiviral prophylaxis. Currently, all such patients will be commenced on life-long entecavir, which is highly effective in preventing reactivation.2 One major disadvantage of using such a blanket approach is that a significant proportion of anti-HBc donors may not actually have underlying occult HBV infection, and recipients of such grafts may not require lifelong antiviral therapy. Current markers such as HBsAg and HBV DNA are not sensitive enough to detect the presence of OBI. This is the first trial proposed to look at the efficacy of these novel HBV biomarkers in identifying occult HBV infection when used in combination, and to identify patients who will not need long term antiviral prophylaxis.

Conditions

Occult Hepatitis B; Liver Transplant; Complications

Keywords

occult hepatitis b; liver transplantation; novel biomarkers

Outcome Measures

Primary Outcomes (1)

• Proportion of HBsAg-negative recipients of an anti-HBc+ graft needing antiviral therapy

  Proportion of HBsAg-negative recipients of an anti-HBc+ graft needing antiviral therapy

  2 years

Secondary Outcomes (1)

• Prevalence of occult hepatitis B infection in HBsAg-/anti-HBc+ donors

  2 years

Study Arms (1)

HBsAg-negative recipients

OTHER

Recipients who are HBsAg-negative will undergo a panel of test to detect HBV viral markers. In addition, real-time PCR will be used to determine the presence of intrahepatic HBV DNA and cccDNA on the explant histology. Patients with evidence of OBI, as characterized by any one positive biomarker (serum HBV DNA, serum HBV RNA, serum HBcrAg, intrahepatic HBV DNA, intrahepatic cccDNA) in either the donor or recipient, will be commenced on life-long oral nucleos(t)ide analog therapy as part of their routine antiviral prophylaxis. For those without evidence of OBI, that is, negative for all biomarkers, no antiviral prophylaxis will be given.

Drug: entecavir

Interventions

entecavir DRUG

Patients with evidence of OBI, as characterized by any one positive biomarker (serum HBV DNA, serum HBV RNA, serum HBcrAg, intrahepatic HBV DNA, intrahepatic cccDNA) in either the donor or recipient, will be commenced on life-long oral nucleos(t)ide analog therapy as part of their routine antiviral prophylaxis.

Also known as: antiviral therapy

HBsAg-negative recipients

Eligibility Criteria

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

You may qualify if:

• \. Patient age ≥18 years undergoing liver transplantation
• \. Donor HBsAg- and anti-HBc+

You may not qualify if:

• \. Recipient of multiple solid organ transplants
• \. Patient undergoing re-transplantation

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Interventions

entecavir

Study Officials

• James Fung, MD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

James Fung, MD

CONTACT

+852 22553830; jfung@gastro.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 3, 2019
• First Posted: December 16, 2019
• Study Start: January 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 23, 2022

Record last verified: 2022-05

Locations

HK (1)