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A real-world study of tenofovir amibufenamide in patients with HBV-associated end-stage liver disease

A real-world study of tenofovir amibufenamide in patients with HBV-associated end-stage liver disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300074529
Enrollment
Unknown
Registered
2023-08-09
Start date
2023-04-01
Completion date
Unknown
Last updated
2023-08-21

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

Conditions

HBV-associated end-stage liver disease

Interventions

Tenofovir amibufenamide antiviral therapy group:No
Entecavir, tenofovir disoproxil fumarate, Entecavir+ tenofovir disoproxil fumarate antiviral therapy group:No

Sponsors

The Third Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: ? The age ranges from 18 to 60; ? It meets the clinical diagnostic criteria of decompensated cirrhosis and chronic acute liver failure in the Guidelines for Diagnosis and Treatment of Liver Failure (2018 Edition); ?HBsAg positive over 6 months; ? Control group: ETV, TDF, ETV+TDF antiviral therapy; ? Observation group: TMF application =2 weeks at the time of enrollment; ? Good compliance and voluntary signing of informed consent

Exclusion criteria

Exclusion criteria: ? < 18 years old or = 60 years old; ? TAF was used to treat HBV; ? Complicated with HCV infection, alcoholic liver disease, autoimmune liver disease, metabolism-related fatty liver disease and other liver diseases; ? Syphilis, HIV and other malignant tumors; ?Other severe acute and chronic extrahepatic diseases that affect prognosis, such as COPD and chronic respiratory failure; Uremic stage of chronic kidney disease (dialysis treatment); Coronary heart disease with left heart failure; ? The patient refused to sign the informed consent to participate in this study; ? None of the above are consistent, but the patient cannot sign the informed consent temporarily due to coma and other reasons, and there is no legal agent to sign instead. Depending on the condition, the patient may not wake up to sign the informed consent.

Design outcomes

Primary

MeasureTime frame
2-year survival rate;

Secondary

MeasureTime frame
HBV DNA;AFP;PIVKA-II;ALB;TBIL;DBIL;CREA;PT;PTA;INR;WBC;RBC;PLT;

Countries

China

Contacts

Public ContactZhao caiyan

The Third Hospital of Hebei Medical University

zhaocy2005@163.com+86 18533112898

Outcome results

None listed

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