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The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss in subjects who stop nucles(t)ide analogues (NAs) (Stop arm) compared to subjects who continue (Continue arm) Only subjects who already are on treatment with ETV, TDF or TAF monotherapy, and have achieved sustained virologic suppression (<20 IU/mL), HBeAg negativity, normal ALT for more than 1 year (pretreatment HBeAg + pts) or 3 years (pretreatment HBeAg - pts), plus qHBsAg <200 IU/mL, and HBV RNA or HBcrAg negativity will be included in this study. One treatment arm will stop the NAs therapy while the other treatment arm will continue the NAs therapy. Participants in the Stop arm will be monitored very closely with special focus on clinical relapse. If any participant in the Stop NAs arm exceeds one or more predefined limits for such flares or relapses, NAs treatment will be reinstituted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stop Arm | Experimental | Stop NAs therapy |
|
| Continue Arm | No Intervention | Continue NAs therapy |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stop NAs therapy | Other | Stop NAs therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With HBsAg Loss at Week 72 in Both Study Arms | HBsAg loss is defined as qualitative HBsAg result changing from positive at baseline (BL) to negative at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate. | Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Sustained Disease Remission at Week 72 in Both Study Arms | Sustained Disease Remission is defined as HBeAg negativity, HBV DNA <2000 IU/mL and ALT normalization at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate. | Week 72 |
| Proportion of Participants With Clinical Relapse at Week 72 in Both Study Arms |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Sun, MD | Contact | 86-20-62787432 | doctorsunjian@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Friendship Hospital, Capital Medical University | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40953786 | Derived | Fan R, Deng R, Xie Q, Wang F, Liang X, Ma H, Rao H, Gao Y, Zhong C, Guo Q, Shen S, Xu Y, Lu X, Gao H, Bai H, Dou X, Sun J. Novel HBV Biomarkers-Guided NAs Withdrawal Strategy Promotes HBsAg Clearance in Asian CHB Patients: A Randomized Controlled Trial. Clin Gastroenterol Hepatol. 2026 Jun;24(6):1611-1620. doi: 10.1016/j.cgh.2025.09.009. Epub 2025 Sep 13. |
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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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Clinical Relapse is defined as HBV DNA >2000 IU/mL and ALT >2 ULN at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate. |
| Week 72 |
| Proportion of Participants With Virologic Relapse at Week 72 in Both Study Arms | Virologic Relapse is defined as HBV DNA >2000 IU/mL at two consecutive timepoints [at least 14 days apart] at any post-baseline visit. Proportions are based on a Kaplan-Meier estimate. | Week 72 |
| Change From Baseline in Quantitative HBsAg (IU/mL) in Both Study Arms | The analyses were summarized by 3 treatment subgroups: Stop NAs (NAs-Free), Restart NAs, and Continue NAs When participant randomized in the Stop NAs group restarted NAs therapy, that participant was considered part of the Restart NAs group from that point forward. For Restart NAs group, baseline is defined as the last available record on or prior to the restart date of NAs. | Week 72 |
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | China |
|
| No. 1 Hospital affiliated to Jilin University | Recruiting | Changchun | Jilin | China |
|
| Shengjing Hospital of China Medical University | Recruiting | Shenyang | Liaoning | China |
|
| Ruijin Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
|
| 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 |