Peg-interferon for Inactive Chronic Hepatitis B Carriers
Status:
Unknown status
Trial end date:
2019-08-01
Target enrollment:
Participant gender:
Summary
Chronic Hepatitis B carriers (normal LFTs and viral load < 2 x 10^4 IU/ml are not recommended
to be treated by guidelines as they are at low risk for complications. However, it is unclear
if treatment can enhance HBsAg loss which has been shown to be associated with significantly
lower risk of complications compared to those without HBsAg loss. Consequently, this is a
proof of concept study to determine the possibility of HBsAg loss in Chronic Hepatitis B
carriers in a randomised open label clinical trial comparing no treatment to 24 weeks
peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised 1:1:1). The primary
endpoint of HBsAg loss will be evaluated 24 weeks after the end of therapy for those on
therapy and matched to an equivalent timepoint in the control arm. The sample size
calculation is 30 patients in each arm for a 20% difference between any experimental arm and
the control arm.