Chronic Hepatitis B. Clinical Trial
Official title:
Determinants of Sustained Virological Response After Discontinuation of Long-term Nucleoside Analogue Therapy in Chronic Hepatitis B Patients
Evaluation of the rate of sustained virological response among HBeAg-negativechronic
hepatitis B patients who discontinue long-term NA therapy.
During this study participants will cease their prescribed medications, this will occur with
immediate effect once enrolled into the study. The duration of cessation will be indefinite,
unless clinically indicated for NA therapy re-start. Participants will be monitored as per
protocol following cessation, monitoring will be by clinic visit and through blood test to
monitor virological response. Clinical visits will be at the intervals of week 2, week, 4,
week 8, week 12, week 18, following this they will be every 3 months out to 2 years when the
participant will have completed the trial. Once the participant has completed the trial they
will not commence again, the aim is for an indefinite cessation of NA therapy.
During this study participants will cease their prescribed medications, this will occur with immediate effect once enrolled into the study. The duration of cessation will be indefinite, unless clinically indicated for NA therapy re-start. Participants will be monitored as per protocol following cessation, monitoring will be by clinic visit and through blood test to monitor virological response. Clinical visits will be at the intervals of week 2, week, 4, week 8, week 12, week 18, following this they will be every 3 months out to 2 years when the participant will have completed the trial. Once the participant has completed the trial they will not commence again, the aim is for an indefinite cessation of NA therapy. ;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment