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NCT04199819: OBI

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

Status unknown NA Last updated 23 May 2022
What this trial tests

NA trial testing entecavir in Occult Hepatitis B in 100 participants. Status unknown.

Timeline
1 January 2022
Primary endpoint
31 December 2023
31 December 2023

Quick facts

Lead sponsorThe University of Hong Kong
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment100
Start date1 January 2022
Primary completion31 December 2023
Estimated completion31 December 2023
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

The University of Hong Kong

Who can join

18 and older, any sex, with Occult Hepatitis B or Liver Transplant; Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other trials of entecavir

Trials testing the same drug.

Other The University of Hong Kong trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04199819.

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