This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Ricovir® (tenofovir disoproxil fumarate 300 mg) 1 tablet daily. The overall treatment period is 24 weeks.
Historical Data
Taichung Veterans General Hospital
Taichung, Taiwan
Assessment of the rates of virological recurrence of HBV
To assess the rates of virological recurrence of HBV at Week 24 with Ricovir® treatment.
Time frame: Week 24
Comparison of the HBV DNA levels between Ricovir® group and historical control group
To compare the HBV DNA levels at Week 24 between Ricovir® group and historical control group.
Time frame: Week 24
Comparison of the rates of virological recurrence of HBV between Ricovir® group and historical control group.
To compare the rates of virological recurrence of HBV at Week 24 between Ricovir® group and historical control group.
Time frame: Week 24
Monitoring of Safety profile for subjects in Ricovir® group
For subjects in Ricovir® group, physical examination, vital signs, HBV DNA level, and concomitant medications will be evaluated at Week 4, 12 and 24 after treatment. Hematology and clinical biochemistry will be performed every 12 weeks. Adverse events (AEs) will be monitored continuously during the study.
Time frame: Up to 24 weeks
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