The safety and effectiveness in CHB patients at week 48 after switching to TAF from ADV containing regimens with HBV DNA undetectable

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1900027289

Enrollment

Unknown

Registered

2019-11-07

Start date

2020-04-01

Completion date

Unknown

Last updated

2019-11-11

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

Conditions

Chronic Hepatitis B

Interventions

ADV or LAM+ADV or Ldt+ADV or ETV+ADV:Switch to TAF

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Male and female aged >18 years adult with CHB in the presence or absence of compensated liver cirrhosis (Child-Pugh class A); 2. Patients with positive serum hepatitis B surface antigen (HBsAg) for at least 6 months were enrolled if they had undetectable serum HBV DNA (<20 IU/mL) at screening and were receiving ADV contained regimens treatment including: (1) ADV monotherapy or De novo combination of LAM+ADV in treatment naive patients; (2) Combination of LAM+ADV in patients with LAM or ADV suboptimal or resistant; (3) Combination of Ldt+ADV in 30 patients with Ldt or ADV suboptimal or resistant; (4) Combination of ETV+ADV in patients with ETV or ADV suboptimal or resistant; (5) Compensated liver disease; 3. Patients who have received ADV-containing regimens for at least one year prior to TAF Switch; 4. Patient is able to give written informed consent prior to study start and to comply.

Exclusion criteria

Exclusion criteria: 1. Women who are pregnant or breastfeeding; 2. Evidence of decompensated liver disease; 3. Positive antibody against hepatitis C, D, or human immunodeficiency virus (anti-HCV, anti-HDV, or anti-HIV); 4. Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease); 5. Current abuse of illegal drugs or alcohol, sufficient in the investigator's opinion to prevent adequate compliance with study therapy or to increase the risk of hepatotoxicity or pancreatitis; 6. Other serious medical conditions that might preclude completion of this study or that require chronic administration of prohibited medications; 7. Moribund state including advanced/pre-terminal liver cancer or other non-hepatic cancers.

Design outcomes

Primary

Measure	Time frame
HBVDNA;eGFR,P,UPCR,UACR,Cr,ß2-MG;BMD;	—

Secondary

Measure	Time frame
ALT;CK;	—

Countries

China

Contacts

Public ContactWang Fusheng

Jumei Foundation

fswang302@163.com+86 13671005510

Outcome results

None listed

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