NCT04501224 is a NA clinical trial of Tenofovir alafenamide fumarate in Chronic Hepatitis b, sponsored by Third Affiliated Hospital, Sun Yat-Sen University.

Who is sponsoring NCT04501224?

NCT04501224 is sponsored by Third Affiliated Hospital, Sun Yat-Sen University.

What drugs are being tested in NCT04501224?

Interventions in NCT04501224: Tenofovir alafenamide fumarate, Entecavir or Tenofovir disoproxil fumarate.

What condition does NCT04501224 study?

NCT04501224 studies Chronic Hepatitis b, Cirrhosis Due to Hepatitis B.

Is NCT04501224 still recruiting?

NCT04501224 is currently status unknown. Last updated 29 October 2020.

Last reviewed 2020-10-29 · How we verify

NCT04501224

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

The Efficacy and Safety of TAF vs Other NAs in Patients With LVL

Status unknown NA Last updated 29 October 2020

What this trial tests

NA trial testing Tenofovir alafenamide fumarate in Chronic Hepatitis b in 200 participants. Status unknown.

Timeline

3 August 2020

Primary endpoint
31 October 2021

30 April 2024

Quick facts

Lead sponsor	Third Affiliated Hospital, Sun Yat-Sen University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	3 August 2020
Primary completion	31 October 2021
Estimated completion	30 April 2024
Sites	1 location across China

Drugs / interventions tested

Tenofovir alafenamide fumarate — full drug profile →
Entecavir or Tenofovir disoproxil fumarate — full drug profile →

Conditions studied

Chronic Hepatitis b — all drugs for Chronic Hepatitis b →
Cirrhosis Due to Hepatitis B — all drugs for Cirrhosis Due to Hepatitis B →

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Who can join

Adults 18 to 80, any sex, with Chronic Hepatitis b or Cirrhosis Due to Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients with chronic hepatitis B should maximize the inhibition of HBV replication, which could reduce the incidence of liver cancer and liver disease-related complications. However, after 96 weeks of treatment with the first-line drugs, entecavir or tenofovir disoproxil fumarate, a certain proportion of patients still had low levels of HBV replication. Tenofovir alafenamide fumarate is a newly marketed anti-hepatitis B drug that is currently considered to be non-inferior to tenofovir disoproxil fumarate and safer bone and renal effects. Therefore, this research was put forward to investigate whether tenofovir alafenamide fumarate replacement for hepatitis B had a higher virological response rate and safety in patients with low levels of virus after 48 weeks of treatment with entecavir and tenofovir disoproxil fumarate.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Tenofovir alafenamide fumarate

Trials testing the same drug.

NCT05195450 — TAF (Tenofovir Alafenamide) for Preventing Progression of Liver Disease in Non-cirrhotic Chronic HBV Infection With Norm · NA · recruiting
NCT02957994 — TAF Switch Study in Hepatitis B Monoinfection · Phase 4 · unknown

Other recruiting trials for Chronic Hepatitis b

Currently open trials in the same condition.

NCT07090759 — To Evaluate the Efficacy, Safety and Population Pharmacokinetics of GST-HG141 in Patients With Chronic Hepatitis B (CHB) · Phase 3 · recruiting
NCT06989788 — A Study to Evaluate the Safety and Immunogenicity of an Investigational Vaccine for Chronic Hepatitis B Virus Infection, · Phase 1 · active not recruiting
NCT06885710 — HBV-Specific TCR-T Cell Therapy Combined With Nucleos(t)Ide Analogues in Chronic Hepatitis B Patients · Phase 1 · recruiting
NCT06671093 — Phase 1b, Open-label Study of Tune-401 to Assess Safety, PK and PD in Adults With Chronic Hepatitis B · Phase 1 · recruiting
NCT06638320 — Hepatitis Delta Virus Infection: Cross-sectional Study in Patients With Chronic Hepatitis B Virus Infection · active not 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 NCT04501224 (US National Library of Medicine, public domain)
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: 29 October 2020

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/NCT04501224.

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