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Efficacy of antiviral therapy in HBeAg-positive chronic hepatitis B with normal ALT and positive HBV DNA: a prospective, non-interventional cohort study

Efficacy of antiviral therapy in HBeAg-positive chronic hepatitis B with normal ALT and positive HBV DNA: a prospective, non-interventional cohort study

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2300075940
Enrollment
Unknown
Registered
2023-09-20
Start date
2023-09-20
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

chronic Hepatitis B

Interventions

Treatment group:None
Control group:None

Sponsors

West China hospital of Sichuan University,China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Detectable hepatitis B surface antigen (HBsAg) for at least 24 weeks, with negative HBeAg and positive hepatitis B e antibody (HBeAb); (2) Continously normal ALT(at least three values of ALT below the upper limit of normal (ULN) within 1 year and at least 3 months apart); (3) Detectable serum HBV DNA (>= 20 IU/mL); (4) HBV treatment-naïve patients, without previous NA or interferon treatment; (5) Volunteering to participate in the study and promise to cooperate in completing the follow-up.

Exclusion criteria

Exclusion criteria: (1)Pregnant or lactating women; (2) Age < 18 years old; (3)Coinfection with other virus, including hepatitis C virus (HCV), hepatitis D virus (HDV), cytomegalovirus(CMV), epstein-Barr virus(EBV), or human immunodeficiency virus(HIV); (4) Suffered from other forms of liver disease, including alcoholic, autoimmune or biliary disease; (5) advanced or significant liver fibrosis by transient elastography or liver biopsy; (6) confirmed liver cirrhosis, HCC or liver transplant patients.

Design outcomes

Primary

MeasureTime frame
Change in level of serum HBV DNA ;Rate of HBeAg seroconversion;Level of serum HBsAg;Scores of liver fibrosis(APRI, FIB-4);Liver stiffness;Scores of health-related quality of life;

Secondary

MeasureTime frame
Rate of negative serum HBsAg;Rate of liver nodules;Rate of liver cirrhosis;Rate of hepatocellular carcinoma ;

Countries

China

Contacts

Public ContactEnqiang Chen

West China Hospital of Sichuan University

chenenqiang1983@hotmail.com+86 189 8060 6517

Outcome results

None listed

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