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A multicenter clinical study of Tenofovir alafenamide Fumarate tablets in the treatment of hepatitis B virus

A multicenter clinical study of Tenofovir alafenamide Fumarate tablets in the treatment of hepatitis B virus

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200060840
Enrollment
Unknown
Registered
2022-06-12
Start date
2022-06-01
Completion date
Unknown
Last updated
2023-03-26

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

Conditions

HBV

Interventions

1:TAF
2:TDF

Sponsors

The Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1.Patients with chronic hepatitis B who are first found positive for hepatitis B surface antigen and need antiviral therapy according to the Guidelines for the Prevention and Treatment of Chronic Hepatitis B (2019 edition) (Figure 1); Or chronic hepatitis B treated with other nucleotide antiviral drugs, but the reexamination of HBV DNA is still positive; 2.18-75 years old; 3.Understand and sign informed consent.

Exclusion criteria

Exclusion criteria: 1.With other types of hepatitis virus or HIV infection; 2.Patients who have participated in other clinical trials in the last 1 month; 3.Women who are pregnant or breastfeeding; 4.Simultaneous use of other antiviral drugs; 5.History of schistosomiasis cirrhosis; 6.intrahepatic cholangiolithiasis with cholangitis; 7.Patients with severe fatty liver; 8.Patients with various autoimmune liver diseases; 9.Patients currently receiving antiviral therapy with interferon -a. 10.Allergic history of TAF, TDF and its components; 11.Acute and chronic renal insufficiency.

Design outcomes

Primary

MeasureTime frame
Liver hardness test;LN;HA;PCIII;Blood routine;

Secondary

MeasureTime frame
Adverse reactions and safety;hepatic and renal function;HBV DNA;blood clotting function;bone mineral density;

Countries

China

Contacts

Public ContactXu Xiao

The Affiliated Hangzhou First People’s Hospital, Zhejiang University School of Medicine

zjxu@zju.edu.cn+86 13588191177

Outcome results

None listed

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