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| Name | Class |
|---|---|
| National Health and Medical Research Council, Australia | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nucleoside analogue therapy cessation | Experimental | To determine if a sustained virological response can be achieved after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucleoside Analogue therapy | Drug | Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| To identify novel immunological determinants of SVR, the assessment will be by serum assay. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gareth Burns, MD | Contact | +61309231 3581 | gareth.burns@svha.org.au |
| Name | Affiliation | Role |
|---|---|---|
| Alexander Thompson, MD | St Vincent's Hospital Melbourne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Recruiting | Melbourne | Victoria | 3065 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41239780 | Derived | Hume SJ, Visvanathan K, Cheng K, Jackson K, Vogrin S, Hall SAL, Burns GS, Desmond PV, Ratnam D, Levy MT, Sawhney R, Strasser SI, Ngu MC, Sinclair M, Meredith C, Matthews G, Valaydon Z, Wong D, Littlejohn M, Holmes JA, Revill PA, Thompson AJ, Warner N. Anti-HBs Immune Complex Levels: A Novel Marker of Hepatitis Flare Following Nucleos(t)ide Analog Withdrawal in HBeAg-negative Chronic Hepatitis B. J Infect Dis. 2026 Mar 17;233(3):e621-e629. doi: 10.1093/infdis/jiaf569. | |
| 40842267 |
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| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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|
| Derived |
| Hume SJ, Hall S, Burns G, Vogrin S, Tassone D, Desmond P, Ratnam D, Levy MT, Sawhney R, Nicoll A, Valaydon Z, Strasser SI, Ngu M, Sinclair M, Meredith C, Matthews GV, Visvanathan K, Holmes JA, Thompson AJ. Long-Term Follow-Up of Patients in a Prospective Study of NA Discontinuation Identifies Different Patterns of HBsAg Loss. Aliment Pharmacol Ther. 2026 Jan;63(2):231-241. doi: 10.1111/apt.70332. Epub 2025 Aug 21. |
| 39007640 | Derived | Hume SJ, Wong DK, Yuen MF, Jackson K, Bonanzinga S, Vogrin S, Hall SAL, Burns GS, Desmond PV, Sundararajan V, Ratnam D, Levy MT, Lubel JS, Nicoll AJ, Strasser SI, Sievert W, Ngu MC, Sinclair M, Meredith C, Matthews G, Revill PA, Littlejohn M, Bowden S, Visvanathan K, Holmes JA, Thompson AJ. High end-of-treatment hepatitis B core-related antigen levels predict hepatitis flare after stopping nucleot(s)ide analogue therapy. Liver Int. 2024 Oct;44(10):2605-2614. doi: 10.1111/liv.16029. Epub 2024 Jul 15. |
| D018347 |
| Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |