A study on the clinical course of chronic hepatitis B under nucleos(t)ide analogue therapy

A study on the clinical course of chronic hepatitis B under nucleos(t)ide analogue therapy - A study on the clinical course of chronic hepatitis B under nucleos(t)ide analogue therapy

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000059333

Enrollment

2500

Registered

2025-10-08

Start date

2025-09-26

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

Chronic hepatitis B

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with chronic hepatitis B who visited the participating institution after the date of approval by the head of the institution and who are either receiving nucleos(t)ide analogue (NA) therapy or not receiving NA therapy Individuals aged 18 years or older at the time of obtaining informed consent Individuals who have continued NA therapy for at least one year (NA treatment group) Individuals who have provided written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: Patients co-infected with HCV or HIV Patients with concomitant hepatocellular carcinoma (HCC) Patients within 3 months after treatment for HCC Patients receiving nucleos(t)ide analogues for the prevention of HBV reactivation Pregnant or lactating women Individuals deemed ineligible by the principal investigator or co-investigators for any other reason

Design outcomes

Primary

Measure	Time frame
Rate of HBV-DNA negativity and associated factors Rate of HBs antigen decline, HBs antigen loss, and associated factors Rate of HBe antigen seroconversion (in HBeAg-positive cases) and associated factors Rate of HB core-related antigen decline and associated factors Rate of ALT normalization and associated factors Rate of initiation of nucleos(t)ide analogue therapy among untreated cases and associated factors Rate of transition from the gray zone to the immune-active phase and associated factors Cumulative incidence of hepatocellular carcinoma and associated factors Cumulative incidence of hepatic decompensation events and associated factors Cumulative rate of esophagogastric variceal aggravation and associated factors Rates of improvement or non-improvement in hepatic fibrosis and hepatic functional reserve, and associated factors Survival rate and associated factors	—

Measure

Time frame

Rate of HBV-DNA negativity and associated factors Rate of HBs antigen decline, HBs antigen loss, and associated factors Rate of HBe antigen seroconversion (in HBeAg-positive cases) and associated factors Rate of HB core-related antigen decline and associated factors Rate of ALT normalization and associated factors Rate of initiation of nucleos(t)ide analogue therapy among untreated cases and associated factors Rate of transition from the gray zone to the immune-active phase and associated factors Cumulative incidence of hepatocellular carcinoma and associated factors Cumulative incidence of hepatic decompensation events and associated factors Cumulative rate of esophagogastric variceal aggravation and associated factors Rates of improvement or non-improvement in hepatic fibrosis and hepatic functional reserve, and associated factors Survival rate and associated factors

—

Secondary

Measure	Time frame
Safety	—

Countries

Japan

Contacts

Public ContactYuki Tahata

The University of Osaka Graduated School of Medicine Department of Gastroneterology and Hepatology

yuki.tahata@gh.med.osaka-u.ac.jp0668793621

Outcome results