A prospective, open-label study to evaluate the safety and efficacy of entecavir or tenofovir disoproxil switching to tenofovir alafenamide in patients with chronic hepatitis B

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

ChiCTR

Registry ID

ChiCTR2300067323

Enrollment

Unknown

Registered

2023-01-04

Start date

2023-01-05

Completion date

Unknown

Last updated

2023-05-15

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

Conditions

chronic hepatitis B

Interventions

group 1:

group 2:

group 3:

group 4:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with HBsAg positive > 6 months, age > 40 years old, treatment-naive meeting the antiviral diagnosis and treatment standards in China's "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 Edition)", or taking oral entecavir or tenofovir disoproxil, or switching to tenofovir alafenamide in chronic hepatitis B patients.

Exclusion criteria

Exclusion criteria: 1. Patients with serious primary diseases such as heart, kidney, hematopoietic system; 2. Those who have mental or cognitive dysfunction and are unable to cooperate with treatment; 3. Pregnant or lactating women; 4. Accompanied by other types of hepatitis virus infection or HIV infection; 5. Patients with glomerular filtration rate (eGFR) < 15 mL/min and not receiving hemodialysis; 6. Patients with life expectancy less than 3 months.

Design outcomes

Primary

Measure	Time frame
urine protein;	—

Secondary

Measure	Time frame
renal function;blood electrolyte;liver function;liver ultrasound;blood lipid profile;blood glucose;liver shear wave elastography;Serum alpha fetoprotein;urine creatinine;Hepatitis B three line quantitative analysis;serum HBV DNA;	—

Countries

China

Contacts

Public ContactYu Jiao

Third Affiliated Hospital of Naval Medical University

yujiao7828@sina.com+86 13818068188

Outcome results

None listed

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