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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.
Full description
2A. Primary Objective
The proportion of subjects with HBsAg loss at Week 24 of followup after treatment with 24 or 48 weeks of pegylated interferon alpha 2a compared to no therapy.
2B. Secondary Objective
The proportion of subjects who experience HBsAg loss with 24 versus 48 weeks of pegylated interferon at the end of treatment, and at end of followup.
The rate of quantitative HBsAg decline in relation to HBsAg loss
The proportion of subjects with virological response (HBV DNA level <13.5IU/mL) at Weeks 12 and 24 of treatment, and week 24 of followup.
2C Study population: 90 patient will be enrolled.
3.1 Inclusion Criteria
For entry into this study, the following inclusion criteria must be met:
3.2 Exclusion Criteria
For entry into this study, the following exclusion criteria must not be met:
4.1 Study Treatment
Product, Dose, and Mode of Administration:
Peginterferon α-2a (PEG), 180mcg, will be administered weekly by subcutaneous injection for the specified period of time (see Study Design, Arms B and C). Pegasys® (Roche Pharmaceuticals).
Reference Therapy, Dose, and Mode of Administration:
Peginterferon α-2a (PEG), 180mcg subcutaneous injection once weekly
4.2 Overview The study will be conducted as a computer randomised clinical trial with concealment of allocation. Patients fulfilling inclusion and exclusion criteria will be randomised after completing screening. Patients will be randomly allocated to three parallel arms: no therapy, 24 weeks peg-interferon alpha 2a, and 48 weeks interferon alpha 2a. Patients will be monitored 4 weekly initial then 12 weekly till end of therapy, then for an additional 24 weeks after completing therapy. Patients on no therapy will be monitored for 72 weeks.
4.3 Endpoints/efficacy assessements Primary: HBsAg loss at end of followup for interferon arms compared to no therapy
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90 participants in 3 patient groups
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Data sourced from clinicaltrials.gov
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