Effectiveness of TAF in Reducing Clinical Events in CHB Patients Beyond Treatment Indications by Current Guidelines

• Status: Recruiting
• Trial end date: 2026-12-31
• Target enrollment: 0
• Participant gender: All

Summary

Treatment with Tenofovir Alafenamide(TAF) in Chronic Hepatitis B (CHB) patients classified as beyond treatment indication of current international guidelines (e.g. aged more than 40 years old and 4 ≤ log HBV-DNA IU/mL < 8) is expected to bring improvement in long-term clinical outcomes. This expected result may expand the treatment indications in patients with CHB based on age and HBV-DNA in contrast to current international guidelines of CHB.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Young-Suk Lim
• Collaborators: Chang Gung Memorial Hospital; Chi Mei Medical Hospital; Chiayi Christian Hospital; China Medical University Hospital; Chung-Ang University Hosptial, Chung-Ang University College of Medicine; Dalin Tzu Chi General Hospital; E-DA Hospital; Kaohsiung Medical University; Konkuk University Medical Center; Korea University Guro Hospital; Kyunghee University Medical Center; Kyungpook National University Hospital; National Cheng-Kung University Hospital; Samsung Medical Center; Seoul National University Hospital; Seoul St. Mary's Hospital; St. Martin De Porress Hospital; Taichung Veterans General Hospital; Taitung Mackay Memorial Hospital; Ulsan University Hospital
• Treatments: Tenofovir

Criteria

Inclusion Criteria: Patients must meet all of the following criteria to be eligible to participate in the study

1. Patient must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures

2. Male or female, 40 to 80 years of age

3. Positive for HBsAg or HBV DNA for at least 6 months or more

4. HBeAg positive or negative

5. No evidence of liver cirrhosis (platelet count ≥100,000/mm3)

6. serum HBV DNA ≥ 4 log10 IU/mL and ≤ 8 log10 IU/mL

7. Serum ALT level ≤70 if male, ≤50 if female

8. Estimated creatinine clearance ≥ 30 ml/min based on serum creatinine as measured at the screening evaluation

9. Patient is willing and able to comply with all study requirements

Exclusion Criteria: Patients who meet any of the following exclusion criteria are not to be enrolled in this study

1. Co-infection with HCV, HDV, HIV (Confirmed by nucleic acid tests)

2. Abusing alcohol (more than 60 g/day) or illicit drugs

3. Patients with history of hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)

4. Evidence of cirrhosis, including any of follows:

1) Platelet count <100,000/mm3 2) Esophagogastric varices on endoscopy 3) Evidence of clinically significant portal hypertension

5. Received interferon or other immunomodulatory treatment for HBV infection in the 12 months before screening for this study

6. Medical condition that requires concurrent use of systemic corticosteroid or other immunosuppressive agents

7. Received solid organ or bone marrow transplant

8. Known hypersensitivity to study drugs, metabolites, or formulation excipients

9. Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the patient unsuitable for the study or unable to comply with dosing requirements

10. Use of investigational agents within 6 months of screening, unless allowed by the Sponsor or Investigator

11. Significant renal, cardiovascular, pulmonary, or neurological disease in the opinion of the Investigator

12. Any malignant tumor in the preceding five years. However, a history of treated malignancy (other than HCC) is allowable if the patient's malignancy has been in complete remission, off chemotherapy and without additional surgical intervention, during the preceding three years

13. Pregnant or breastfeeding or willing to be pregnant

14. Participating in other clinical trials to administer medication. However, it is possible to participate if it is not an antiviral agent or immunosuppressant related clinical trial.