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Association between serum HBV markers and the incidence of developing hepatocellular carcinoma in patients with chronic hepatitis B receiving nucleos(t)ide analogues

Association between serum HBV markers and the incidence of developing hepatocellular carcinoma in patients with chronic hepatitis B receiving nucleos(t)ide analogues - Association between serum HBV markers and the incidence of developing hepatocellular carcinoma in patients with chronic hepatitis B receiving nucleos(t)ide analogues

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000012423
Enrollment
1500
Registered
2013-11-27
Start date
2013-12-01
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

Sponsors

Osaka University Graduate School of Medicine, Department of Gastroenterology and Hepatology
Lead Sponsor
Itami City Hospital Higashiosaka City Central Hospital Otemae Hospital Sumitomo Hospital Nishinomiya Municipal Central Hospital National Hospital Organization Osaka National Hospital Osaka Police Hospital NTT West Osaka Hospital Kansai Rosai Hospital Osaka Koseinenkin Hospital Yao Municipal Hospital Suita Municipal Hospital Ashiya Municipal Hospital Saiseikai Senri Hospital Hyogo Prefectural Nishinomiya Hospital National Hospital Organization Osaka Minami Medical Center Toyonaka
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients with chronic hepatits B treated with nucleos(t)ide analogues for more than 1 year

Exclusion criteria

Exclusion criteria: under age of 20 coinfection with HCV / HDV / HIV coexistence with other chronic liver disease pregnant or breast-feeding women coexistence with severe disease of other organs, or immunodeficiency patients found to be inadequate by their doctors

Design outcomes

Primary

MeasureTime frame
the cumulative incidence of hepatocellular carcinoma decline of HB surface antigen, loss of HB surface antigen decline of HB core-related antigen suppression of HBV DNA (<2.6LC/mL) ALT normalization HBe antigen seroconversion (applied in patients positive for HBe antigen att baseline)

Countries

Japan

Contacts

Public ContactRyoko Yamada

Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology

ryo726@gh.med.osaka-u.ac.jp06-6879-3621

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026