The research of safety and liver dysfunction in IBD patients with HBV treated with immunomodulatory treatments.

The research of safety and liver dysfunction in IBD patients with HBV treated with immunomodulatory treatments. - The research of safety and liver dysfunction in IBD patients with HBV treated with immunomodulatory treatments.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000009730

Enrollment

4500

Registered

2013-01-08

Start date

2007-01-04

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

Inflammatory bowel disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: UC and CD were diagnosed based on radiologic, endoscopic and histopathologic criteria.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
1.The prevalence of HBV infection The number of patients with HBsAg-positive The number of patients with HBsAb-positive and/or HBcAb-positive 2.The safety of medications The prevalence of liver dysfunction* related to HBV and HBV reactivation Liver dysfunction is defined as an increase of 1.5-2-fold the baseline value ALT. Reactivation of HBV is defined as an increase of >2000IU/ml plus liver dysfunction (as above). /**Loras et al. Gut 2010	—

Measure

Time frame

1.The prevalence of HBV infection The number of patients with HBsAg-positive The number of patients with HBsAb-positive and/or HBcAb-positive 2.The safety of medications The prevalence of liver dysfunction* related to HBV and HBV reactivation *Liver dysfunction is defined as an increase of 1.5-2-fold the baseline value ALT. **Reactivation of HBV is defined as an increase of >2000IU/ml plus liver dysfunction (as above). */**Loras et al. Gut 2010

—

Countries

Japan

Contacts

Public ContactYoko Yokoyama

Hyogo College of Medicine Department of Internal Medicine, Division of Lower Gastroenterology

yoko0502@hyo-med.ac.jp0798-45-6111

Outcome results