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This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.
Hepatitis b virus infection has always been a global public health problem that endangers national health. Current clinical guidelines do not recommend antiviral therapy for people with positive hepatitis b-DNA and normal Alanine Aminotransferase, but studies have found that viral replication is associated with an increased risk of cirrhosis and liver tumors. Nucleoside (acid) analogues can effectively inhibit viral reverse transcriptase, reduce HBV viral load in the blood, thereby reducing secondary inflammation, and contribute to liver cell regeneration and disease recovery. And its side effect is small, adverse reaction rate is low, use safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TAF group | Active Comparator | 100 patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF) 25 mg once per day from baseline to life-long unless the patient achieves HBsAg loss. |
|
| Observation group | No Intervention | 100 patients would not receive treatment from baseline to life-long. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir alafenamide Fumarate | Drug | Patients would receive treatment of oral Tenofovir alafenamide Fumarate(TAF)once per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| hepatitis b s antigen decrease from baseline | Magnitude of decrease in hepatitis B antigen quantification from baseline to week 144. | 48 week, 96 week, 144 week |
| Measure | Description | Time Frame |
|---|---|---|
| hepatitis b e antigen loss rate | Hepatitis b e antigen would be tested to know the ratio of patients with negative hepatitis B e antigen. | 48 week, 96 week, 144 week |
| hepatitis b virus(HBV) DNA undetectable rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiumin Luo, Doctor | Contact | +8613632399075 | lqiumin@126.com | |
| Liang Peng, Doctor | Contact | +8613533978874 | pzp33@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Liang Peng, Doctor | Third Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42095461 | Derived | Luo Q, Xu R, Zhang Y, Xu W, Li X, Lai J, Li J, Zheng X, Deng H, Chen L, Zhu X, Xie C, Peng L. Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Virus Infection in the High-Replicative Low-Inflammatory Phase: A 48-Week Randomized Controlled Trial. J Med Virol. 2026 May;98(5):e70960. doi: 10.1002/jmv.70960. | |
| 41608776 | Derived |
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Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.
Beginning 3 months and ending 5 years following the article publication.
Proposals should be directed to xxx@yyy. To gain access, data requestors need to sign a data access agreement.
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C442442 | tenofovir alafenamide |
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Hepatitis b virus DNA would not be detected if it below the upper limit of test value
| 48 week, 96 week, 144 week |
| hepatitis b virus(HBV) RNA undetectable rate | Hepatitis b virus RNA would not be detected if it below the upper limit of test value | 48 week, 96 week, 144 week |
| hepatitis b s antigen loss rate | Hepatitis b s antigen become negative and quantitative analysis below the upper limit of test value | 48 week, 96 week, 144 week |
| Luo Q, Xu W, Zhang Y, Li X, Lai J, Li J, Zheng X, Deng H, Chen L, Zhu X, Xie C, Peng L. Tenofovir Alafenamide Fumarate Reduces Virological Replication in HBeAg-Negative Patients With Normal Alanine Aminotransferase: A 48-Week Randomised Controlled Trial. J Viral Hepat. 2026 Mar;33(3):e70141. doi: 10.1111/jvh.70141. |
| 35435091 | Derived | Wang L, Zhu S, Liu Y, Zheng L, Xu W, Luo Q, Zhang Y, Deng H, Li X, Xie C, Peng L. Prognostic value of decline in model for end-stage liver disease score and hepatic encephalopathy in hepatitis B-related acute-on-chronic liver failure patients treated with plasma exchange. Scand J Gastroenterol. 2022 Sep;57(9):1089-1096. doi: 10.1080/00365521.2022.2063032. Epub 2022 Apr 17. |
| 35366805 | Derived | Wang L, Xu W, Li X, Chen D, Zhang Y, Chen Y, Wang J, Luo Q, Xie C, Peng L. Long-term prognosis of patients with hepatitis B virus-related acute-on-chronic liver failure: a retrospective study. BMC Gastroenterol. 2022 Apr 2;22(1):162. doi: 10.1186/s12876-022-02239-4. |
| 34408049 | Derived | Wang L, Wu L, Li X, Zhang Y, Lai J, Zhu X, Xie C, Peng L. Tenofovir alafenamide fumarate therapy in subjects with positive HBV-DNA and normal levels of alanine transaminase: a study protocol for a randomised controlled trial. BMJ Open. 2021 Aug 18;11(8):e048410. doi: 10.1136/bmjopen-2020-048410. |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |