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A prospective randomized controlled study to evaluate the benefit of antiviral therapy in HBV infected patients with normal ALT and positive HBV DNA

A prospective randomized controlled study to evaluate the benefit of antiviral therapy in HBV infected patients with normal ALT and positive HBV DNA

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300069391
Enrollment
Unknown
Registered
2023-03-15
Start date
2023-03-15
Completion date
Unknown
Last updated
2023-05-29

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:nucleos(t)ide analogues treatment
Control group:no nucleos(t)ide analogues therapy

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Detectable hepatitis B surface antigen (HBsAg) levels for at least 6 months, undetectable HBeAg and detectable HBeAb before screening; 2. At least three ALT values less than the upper limit of normal range within one year that were at least 3 months apart (the upper limits of normal ALT were 50U/L for male and 40U/L for female, respectively); 3. Detectable HBV DNA (>= 20 IU/mL); 4. No signs of cirrhosis or liver nodules by liver ultrasound; 5. HBV treatment na?ve, including NAs or interferon; 6 .Volunteering to participate in the study and commit to cooperate with the completion of follow-up.

Exclusion criteria

Exclusion criteria: 1. Pregnant women; 2. Age < 18; 3. Coinfection with HIV, HCV, or HDV; 4. Suffered from other forms of liver disease, for example, alcoholic, autoimmune or biliary disease; 5. Confirmed diagnosis of liver cirrhosis, primary liver cancer or liver metastasis.

Design outcomes

Primary

MeasureTime frame
loads of serum HBV DNA;loads of serum HBV RNA;quality of life;

Secondary

MeasureTime frame
live nodules;liver stiffness;hepatocellular carcinoma (HCC);

Countries

China

Contacts

Public ContactEnqiang Chen

West China Hospital of Sichuan University

chenenqiang1983@hotmail.com+86 18980606517

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026