A Phase 4 interventional study of Tenofovir alafenamide and Entecavir in Hepatitis B and Viral Hepatitis, sponsored by Taichung Veterans General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by Taichung Veterans General Hospital · Phase 4, Interventional, and Treatment
To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.
With high antiviral potency and low drug resistance rate, both ETV and tenofovir disoproxil fumarate (TDF) have been recommended as the first-line antiviral therapy for chronic hepatitis B (CHB). However, risk of renal dysfunction remains an issue in TDF long-term therapy. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at lower doses, thereby reducing systemic exposure to tenofovir. Importantly, TAF had improved renal safety as compared to TDF. TAF has been approved for treating CHB since 2017; however, it is still unknown whether the efficacy and renal safety of TAF is compatible to those of ETV. The investigators aim to conduct an open label, randomized controlled trial comparing TAF with ETV for assessing their efficacy and renal safety in CHB patients. The eligible CHB patients are randomly assigned (1:1) to receive TAF or ETV. After allocation to TAF group or ETV group, study subjects will receive therapy for 3 years (144 weeks).
1,045 studies on the registry are indexed under Hepatitis B; 139 are open to participants now.
This study's planned enrollment of 140 is close to the median of 147 across 756 interventional studies indexed under Hepatitis B.
Browse Hepatitis B studies →Taichung Veterans General Hospital is the lead sponsor of 175 studies on the registry; 39 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Study subjects will receive tenofovir alafenamide 25 mg/tab once daily
Drug: Tenofovir alafenamide
Study subjects will receive entecavir 0.5 mg/tab once daily
Drug: Entecavir
Tenofovir alafenamide 25mg/tab once daily
Also known as: Vemlidy
Entecavir 0.5mg/tab once daily
Also known as: Baraclude
HBV viral suppression
proportion of patients with hepatitis B virus(HBV) -DNA suppression
Time frame: After 48-week therapy of Tenofovir alafenamide or entecavir
Renal safety: Change of estimated glomerular filtration rate
Change of estimated glomerular filtration rate
Time frame: After 48-week therapy of Tenofovir alafenamide or entecavir
Renal safety: Change of estimated glomerular filtration rate
Change of estimated glomerular filtration rate
Time frame: After 144-week therapy of Tenofovir alafenamide or entecavir
HBV viral suppression
proportion of patients with hepatitis B virus(HBV) -DNA suppression
Time frame: After 144-week therapy of Tenofovir alafenamide or entecavir
Normalization alanine aminotransferase (ALT)
proportion of patients with ALT normalization
Time frame: After 144-week therapy of Tenofovir alafenamide or entecavir
HBsAg loss
proportion of patients with HBsAg loss
Time frame: After 144-week therapy of Tenofovir alafenamide or entecavir
Bone mineral density
change of bone mineral density
Time frame: After 144-week therapy of Tenofovir alafenamide or entecavir
Plan to share: No
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Studies of the drugs tested here: Tenofovir alafenamide · Entecavir
Taichung Veterans General Hospital →