The efficacy and safety of two first-line antiviral drugs in chronic hepatits B patients with high viral load

The efficacy of monotherapy or combination therapy with tenofovir alafenamide and entacavir in chronic hepatits B patients with high viral load: a realworld study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000039239

Enrollment

Unknown

Registered

2020-10-22

Start date

2020-11-01

Completion date

Unknown

Last updated

2021-01-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic hepatits B

Interventions

TAF/ETV combined group:TAF/ETV combined therapy,TAF 25mg/day, ETV 0.5mg/day

TAF mono therapy group:TAF 25mg/day

ETV mono therapy group:ETV 0.5mg/day

Eligibility

Sex/Gender

Male

Inclusion criteria

Inclusion criteria: 1. HBsAg or HBVDNA positive for more than half a year; 2. HBVDNA > 1*10E7 IU/ml; 3. Aged between 18-65 years; 4. Fall into antiviral therapy indications of guidelines for the prevention and treatment of chronic hepatitis B (China, 2019 version); 5. Treatment naive patients.

Exclusion criteria

Exclusion criteria: 1. Coinfection with HAV,HCV,HDV,HEV,HIV; 2. Pregnant or breastfeeding women; 3. Other abnormal conditions according to investigators judgement; 4. Unable to sign informed consent.

Design outcomes

Primary

Measure	Time frame
HBV DNA quantification;Alanine aminotransferase;HBeAg quantification;HBsAg quantification;Ultrasound;Liver stiffness;Bone density;Urine rountine test;	—

Countries

China

Contacts

Public ContactCao Hong

The Third Affiliated Hospital of Sun Yat-Sen University

Billcaohong@163.com+86 18922103791

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026