Finite Versus Continuous Nucleos(t)Ide Analogues for Chronic Hepatitis B
Status:
Active, not recruiting
Trial end date:
2026-12-01
Target enrollment:
Participant gender:
Summary
BACKGROUND:
Finite nucleos(t)ide analogue (Nuc) therapy was proposed as an alternative strategy in the
management of chronic hepatitis B (CHB) but there remained not data from randomized
controlled trials to clarify safety and efficacy of this treatment strategy.
AIMS:
The investigators aimed to evaluate the safety and efficacy of finite Nuc therapy versus
continuous treatment in CHB patients without liver cirrhosis and also to identify factors
that may predict therapeutic responses and clinical outcomes after withdrawal of Nuc
treatment for CHB
MATERIAL AND METHODS:
This is a multicenter randomized controlled trial conducted in Taiwan. Eligible patients are
adults (age≥20 years) with CHB (chronic infection ≥ 6 months) who fulfill the APASL guideline
2016 to stop NA therapy. Those with cirrhosis, malignancy, organ transplant, autoimmune
disorder, or serious underlying diseases including renal impairment were excluded. A total of
360 patients will be enrolled. Enrolled patients are randomly allocated with a 1:1 ratio to
continue viral suppression with entecavir (0.5mg once daily) or tenofovir disoproxil fumarate
(300mg once daily) or stop the treatment. All patients will be followed up according to the
protocol recommended by a panel of APASL experts. The primary analysis for study outcomes is
scheduled at 3 years after randomization and the primary outcome is seroclearance of HBsAg.
There will be interim analyses scheduled at one- and two-years following randomization of the
first 200 patients, and also one-and two years following randomization of the planned 360
patients, to determine whether early termination of the trial may be justified by attainment
of the efficacy endpoint (10% vs 1% of HBsAg seroclearance) or concerns of the safety
outcomes (significant between-group difference in mortality, acute on chronic liver failure,
or acute flares with hepatic decompensation).