Determinants of Virological Response After Discontinuation of Nucleoside Analogue Therapy in Hepatitis B Patients (STOP)
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Determinants of Sustained Virological Response After Discontinuation of Long-term Nucleoside Analogue Therapy in Chronic Hepatitis B Patients|
- The primary aim of this study is to evaluate the rate of sustained virological response among HBeAg-negative chronic hepatitis B patients who discontinue long-term NA therapy. The outcome is to be assessed by serum assay. [ Time Frame: Patients will be closely followed for 2 years prospectively, at the following time points; 2 weeks post cessation, 4 weeks, 8 weeks, 12 weeks, 18 weeks, then from 6 months the visits will be 3 monthly out to two years, to observe for virological changes. ] [ Designated as safety issue: Yes ]
- To identify novel immunological determinants of SVR, the assessment will be by serum assay. [ Time Frame: Patients will be closely followed for 2 years prospectively, at the following time points; 2 weeks post cessation, 4 weeks, 8 weeks, 12 weeks, 18 weeks, then from 6 months the visits will be 3 monthly out to two years. ] [ Designated as safety issue: Yes ]
|Study Start Date:||May 2014|
|Estimated Study Completion Date:||May 2018|
|Estimated Primary Completion Date:||May 2018 (Final data collection date for primary outcome measure)|
Experimental: Nucleoside analogue therapy cessation
To determine if a sustained virological response can be achieved after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.
Drug: Nucleoside Analogue therapy
Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.
Other Name: Cessation of Nucleoside Analogue Therapy
Please refer to this study by its ClinicalTrials.gov identifier: NCT02581033
|Contact: Gareth Burns, MD||+61309231 email@example.com|
|St Vincent's Hospital||Recruiting|
|Melbourne, Victoria, Australia, 3065|
|Contact: Gareth Burns, MD +61392313581 firstname.lastname@example.org|
|Contact: John Gough, RN +61392313518 email@example.com|
|Principal Investigator:||Alexander Thompson, MD||St Vincent's Hospital Melbourne|