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TAF monotherapy resulted in (extremely) low viremia with prolonged liver fibrosis in CHB patients, who switched to TMF for salvage treatment: A multicenter, randomized controlled, prospective study

TAF monotherapy resulted in (extremely) low viremia with prolonged liver fibrosis in CHB patients, who switched to TMF for salvage treatment: A multicenter, randomized controlled, prospective study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120403
Enrollment
Unknown
Registered
2026-03-13
Start date
2025-05-08
Completion date
Unknown
Last updated
2026-03-16

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

Conditions

Chronic hepatitis B

Interventions

TMF sequential treatment group:Adefovir (TMF) sequential therapy
TAF maintenance treatment group:Tenofovir alafenamide (TAF) maintenance therapy

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.HBsAg positive for at least 6 months before enrollment; 2. HBeAg negative; 3.The serum HBV-DNA is between 10-100 IU/mL, and the serum ALT is within the normal range 4.Transient imaging of liver elasticity confirmed the presence of advanced liver fibrosis (9 kPa = LSM<12 kPa); 5. Prior to enrollment, only TAF antiviral therapy was used and no anti liver fibrosis drugs were used; 6.The diagnosis of CHB meets the diagnostic criteria of the "Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2022 Edition)"; 7.Voluntarily participate in the study and promise to cooperate in completing the follow-up.

Exclusion criteria

Exclusion criteria: 1.Pregnant or lactating women; 2. Age under 18 years old or over 65 years old; 3.Merge other viral infections such as hepatitis virus, CMV, EBV, and HIV; 4. Combining alcoholic, metabolic, drug-induced, or autoimmune liver diseases; 5.Patients with cirrhosis, liver cancer, and liver transplantation.

Design outcomes

Primary

MeasureTime frame
alpha-fetoprotein;HBsAg Loss;HBV DNA seroconversion rate;HBV RNA seroconversion rate;Liver Stiffness Measurement;Hemoglobin;White Blood Cell Count;Platelet Count;

Secondary

MeasureTime frame
Quality of Life Rating;Adverse reaction;Alanine aminotransferase;Bilirubin metabolism;Albumin;Prothrombin time;Serum creatinine;Estimated glomerular filtration rate;

Countries

China

Contacts

Public ContactEnqiang Chen

West China Hospital, Sichuan University

chenenqiang1983@hotmail.com+86 189 8060 6517

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026