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A clinical study on the incidence and clinical strategies of low-level viremia in chronic hepatitis B patients treated with nucleus ( t) ide analogues

A clinical study on the incidence and clinical strategies of (extremely) low-levelviremia in chronic hepatitis B patients treated with nucleus ( t) ide analogues

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400089366
Enrollment
Unknown
Registered
2024-09-06
Start date
2023-07-04
Completion date
Unknown
Last updated
2024-09-09

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

Conditions

Chronic viral hepatitis B

Interventions

(very)low-level viremia group/complete virological response group:None

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Over 18 years old; 2. Patients who have received TDF, ETV, or TAF treatment for no less than 12 months and have a ordinary HBV DNA<100IU/ml; 3. Before antiviral treatment, the serum hepatitis B surface antigen remains positive for 6 months or more.

Exclusion criteria

Exclusion criteria: 1. Lack of baseline clinical data; 2.Co-infection with other viral hepatitis or human immunodeficiency virus; 3. Co-existing with drug-induced liver disease, hereditary liver disease, autoimmune hepatitis, and other serious diseases; 4. History of HCC or other malignant tumors; 5. Combined treatment with other antiviral drugs, such as ETV+TDF, nucleoside analogues+interferon; 6. Failed to complete two consecutive hyper-sensitivity HBV DNA tests (with a lower limitation of 10IU/ml)

Design outcomes

Primary

MeasureTime frame
HBV DNA seroconversion rate;

Secondary

MeasureTime frame
change of APRI;change of FIB-4 score;ALT normalization rate;Incidence of cirrhosis;Incidence of liver cancer;

Countries

China

Contacts

Public ContactChen Enqiang

West China Hospital, Sichuan University

chenenqiang1983@hotmail.com+86 189 8060 6517

Outcome results

None listed

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