Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tenofovir alafenamide Fumarate.
- Who it may be relevant to
- Registry conditions: Hepatitis B Virus. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study on Therapeutic Effects and Safety of Nucleoside (Acid) Analogues Treatment in Patients With Chronic Hepatitis B With Normal Alanine Aminotransferase and Positive Hepatitis B Virus DNA: a Randomized Controlled Trial
Overview
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.
Detailed description
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.
Interventions
- Drug Tenofovir alafenamide Fumarate
Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.
Primary outcome measures
- hepatitis b s antigen decrease from baseline [Time frame: 48 week, 96 week, 144 week]
Secondary outcome measures (4)
- hepatitis b e antigen loss rate [Time frame: 48 week, 96 week, 144 week]
- hepatitis b virus(HBV) DNA undetectable rate [Time frame: 48 week, 96 week, 144 week]
- hepatitis b virus(HBV) RNA undetectable rate [Time frame: 48 week, 96 week, 144 week]
- hepatitis b s antigen loss rate [Time frame: 48 week, 96 week, 144 week]
Eligibility criteria
Inclusion criteria
- Positive hepatitis b surface antigen and hepatitis b antibody > 0.5 year;
- Age from 18 to 65 years old;
- Serum Alanine Aminotransferase(ALT) ≤1×ULN at least 12 weeks;
- Positive Hepatitis b virus(HBV);
- Do not receive nucleotide/nucleoside analogues or interferon treatment in the past half year.
Exclusion criteria
- Other active liver diseases;
- Hepatocellular carcinoma or other malignancy;
- Pregnancy or lactation;
- Human immunodeficiency virus infection or congenital immune deficiency diseases; 5.Severe diabetes, autoimmune diseases; 6.Other important organ dysfunctions; 7.Using glucocorticoid; 8.Patients can not follow-up; 9.Investigator considering inappropriate.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Third Affiliated Hospital of Sun Yat-sen University — Guangzhou
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. PMID 42095461
- 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. PMID 41608776
- 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. PMID 35435091
- 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. PMID 35366805
- 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. PMID 34408049
Identifiers
NCT: NCT04231565 · PL10