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NCT04674423
The Effectiveness and Safety of Tenofovir Alafenamide in the Treatment of Chronic Hepatitis B Patients With Mildly Elevated Alanine Aminotransferase and Significant Liver Injury.
Phase 4 trial testing Tenofovir Alafenamide in Chronic Hepatitis b in 40 participants. Status unknown.
31 December 2025
Quick facts
| Lead sponsor | National Cheng-Kung University Hospital |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 14 May 2020 |
| Primary completion | 31 December 2025 |
| Estimated completion | 31 December 2025 |
| Sites | 1 location across Taiwan |
Drugs / interventions tested
- Tenofovir Alafenamide (TENOFOVIR ALAFENAMIDE) — full drug profile →
Conditions studied
- Chronic Hepatitis b — all drugs for Chronic Hepatitis b →
Sponsor
National Cheng-Kung University Hospital
Who can join
20 and older, any sex, with Chronic Hepatitis b. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
In Taiwan, non-cirrhosis CHB patients with mildly elevated ALT are not candidates for antiviral treatment under Taiwan NIH reimbursement criteria. Disease severity could range from mildly liver injury to cirrhosis in this group of patients. There is a substantial population of patients required antiviral treatment, but not fulfill the criteria of reimbursement treatment. For the 2 phase 3 trials of TAF, the treatment criteria of ALT were more than 2x of ULN and did not included liver biopsy as a pre-treatment assessment. In this study, CHB patient with ALT level of 1-2x ULN and significant liver injury evaluated by liver biopsy is the target study population.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Role of pharmacogenetics and tacrolimus dosing in liver transplantation.
Fung J. · · 2023 · cited 5× · PMID 36284080 · DOI 10.1007/s12072-022-10437-1 -
Abstract
· 2022
Verify or expand the search:
- PubMed search for NCT04674423
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Tenofovir Alafenamide
Trials testing the same drug.
- NCT05467553 — A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection · Phase 2 · unknown
- NCT05275023 — An Efficacy and Safety Study of a Combination of JNJ-73763989, Nucleos(t)Ide Analogs (NA), and a Programmed Cell Death P · Phase 2 · completed
- NCT04891770 — Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of · Phase 2 · completed
- NCT03887702 — Prophylactic Antiviral Therapy in Patients With Current or Past Hepatitis B Virus Infection Receiving Anti-Cancer Therap · Phase 3 · terminated
- NCT03798119 — TAF Switch in F3/4 CHB pt With Partial Response to NUC (ESTAB-AFPVR) · 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 National Cheng-Kung University Hospital trials
Trials by the same sponsor.
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- NCT07257926 — Prevention of Delayed Post-polypectomy Bleeding by Endoscopic Sucralfate Spray in High-risk Patients: A Randomized Contr · Phase 4 · not yet recruiting
- NCT07269132 — Applying the ADDIE Model to Develop a Multimedia Program to Enhance Chemotherapy Knowledge and Self-Efficacy Among Inten · NA · enrolling by invitation
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04674423 (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 National Cheng-Kung University Hospital
- Last refreshed: 22 December 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/NCT04674423.
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