NCT04231565 (ALTHBV) is a NA clinical trial of Tenofovir alafenamide Fumarate in Hepatitis B Virus, sponsored by Third Affiliated Hospital, Sun Yat-Sen University.

Who is sponsoring NCT04231565?

NCT04231565 is sponsored by Third Affiliated Hospital, Sun Yat-Sen University.

What drugs are being tested in NCT04231565?

Interventions in NCT04231565: Tenofovir alafenamide Fumarate.

What condition does NCT04231565 study?

NCT04231565 studies Hepatitis B Virus.

Is NCT04231565 still recruiting?

NCT04231565 is currently recruiting now. Last updated 1 March 2024.

Last reviewed 2024-03-01 · How we verify

NCT04231565: ALTHBV

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.

Recruiting now NA Last updated 1 March 2024

What this trial tests

NA trial testing Tenofovir alafenamide Fumarate in Hepatitis B Virus in 200 participants. Currently enrolling.

Timeline

4 June 2020

Primary endpoint
1 June 2024

1 July 2027

Quick facts

Lead sponsor	Third Affiliated Hospital, Sun Yat-Sen University
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	4 June 2020
Primary completion	1 June 2024
Estimated completion	1 July 2027
Sites	1 location across China

Drugs / interventions tested

Tenofovir alafenamide Fumarate — full drug profile →

Conditions studied

Hepatitis B Virus — all drugs for Hepatitis B Virus →

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Who can join

Adults 18 to 65, any sex, with Hepatitis B Virus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

Long-term prognosis of patients with hepatitis B virus-related acute-on-chronic liver failure: a retrospective study.
Wang L, Xu W, Li X, Chen D, et al · · 2022 · cited 9× · PMID 35366805 · DOI 10.1186/s12876-022-02239-4
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.
Wang L, Zhu S, Liu Y, Zheng L, et al · · 2022 · cited 4× · PMID 35435091 · DOI 10.1080/00365521.2022.2063032
Tenofovir Alafenamide Fumarate Reduces Virological Replication in HBeAg-Negative Patients With Normal Alanine Aminotransferase: A 48-Week Randomised Controlled Trial.
Luo Q, Xu W, Zhang Y, Li X, et al · · 2026 · cited 1× · PMID 41608776 · DOI 10.1111/jvh.70141
Tenofovir alafenamide fumarate therapy in subjects with positive HBV-DNA and normal levels of alanine transaminase: a study protocol for a randomised controlled trial.
Wang L, Wu L, Li X, Zhang Y, et al · · 2021 · cited 1× · PMID 34408049 · DOI 10.1136/bmjopen-2020-048410
Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Virus Infection in the High-Replicative Low-Inflammatory Phase: A 48-Week Randomized Controlled Trial.
Luo Q, Xu R, Zhang Y, Xu W, et al · · 2026 · PMID 42095461 · DOI 10.1002/jmv.70960
Long-Term Prognosis of Patients with Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Retrospective Study
Wang L, Xu W, Li X, Chen D, et al · · 2021 · DOI 10.21203/rs.3.rs-1007041/v1

Verify or expand the search:

Other recruiting trials for Hepatitis B Virus

Currently open trials in the same condition.

NCT06881238 — Impact of Hepatitis B Virus on Inflammatory Bowel Disease · recruiting

Other Third Affiliated Hospital, Sun Yat-Sen University trials

Trials by the same sponsor.

NCT07409259 — PT-MSCs Exosome Injection in the Treatment of Chronic-to-acute Liver Failure · EARLY_PHASE1 · active not recruiting
NCT07281664 — Transarterial Chemoembolization With Low-Dose Bevacizumab Plus Atezolizumab as First-Line Treatment for Unresectable Hep · NA · not yet recruiting
NCT07338552 — Effectiveness of a Virtual Health Management Community (VHMC) for Pre-diabetes in China · NA · not yet recruiting
NCT07354997 — Establishing a Virtual Health Community Management Model for Pre-Diabetes Patients · NA · completed
NCT07253233 — Treatment of Spinal Cord Injury Using Autologous Concentrated Growth Factors · EARLY_PHASE1 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04231565 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Third Affiliated Hospital, Sun Yat-Sen University
Last refreshed: 1 March 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04231565.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing