drugset / Trial / NCT04231565
Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.
RandomizedParallel-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2020-06-04
- Primary completion
- 2024-06-01
- Completion
- 2027-07-01
Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | tenofovir alafenamide | Small molecule | 25 mg | Oral |