Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.
ALTHBV
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
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 13, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
June 4, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedMarch 1, 2024
February 1, 2024
4 years
January 13, 2020
February 28, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (4)
hepatitis b e antigen loss rate
48 week, 96 week, 144 week
hepatitis b virus(HBV) DNA undetectable rate
48 week, 96 week, 144 week
hepatitis b virus(HBV) RNA undetectable rate
48 week, 96 week, 144 week
hepatitis b s antigen loss rate
48 week, 96 week, 144 week
Study Arms (2)
TAF group
ACTIVE COMPARATOR100 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 INTERVENTION100 patients would not receive treatment from baseline to life-long.
Interventions
Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Third Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Related Publications (4)
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: 41608776DERIVEDWang 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: 35435091DERIVEDWang 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: 35366805DERIVEDWang 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: 34408049DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liang Peng, Doctor
Third Affiliated Hospital, Sun Yat-Sen University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professer
Study Record Dates
First Submitted
January 13, 2020
First Posted
January 18, 2020
Study Start
June 4, 2020
Primary Completion
June 1, 2024
Study Completion (Estimated)
July 1, 2027
Last Updated
March 1, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Beginning 3 months and ending 5 years following the article publication.
- Access Criteria
- Proposals should be directed to xxx@yyy. To gain access, data requestors need to sign a data access agreement.
Individual participant data that underline the results reported in this article (text, tables, figures and appendices) will be shared.