ationwide Long-Term Survey of Hepatitis B Virus Reactivation in Patients Receiving Immunosuppressive Drugs to Establish the Therapeutic Strategy to Prevent Severe Liver Injury.

Not Applicable

• Conditions: HBV-infected patients

• Registration Number: JPRN-UMIN000008875
• Lead Sponsor: Saitama Medical University

Brief Summary

A total of 289 patients with previously resolved HBV infection, consisting of 200 patients with rheumatoid diseases, 44 patients with skin diseases, 28 patients with intestinal diseases, and 17 patients with ophthalmological diseases, were enrolled. Seventy-two patients were enrolled before the initiation of immunosuppressive therapies, but 217 patients were enrolled after the initiation of immunosuppressive therapy. Serum HBV-DNA became detectable in 9 patients (3.1%) at a median of 25 months, ranging from 4 to 201 months after the initiation of immunosuppressive therapy, and the levels exceeded 1.3 Log IU/mL in 5 patients (1.7%) .Among these 5 patients with HBV reactivation, the serum HBV-DNA levels were further increased in only 1 patient at 1 month thereafter; in the remaining 4 patients, the serum HBV-DNA level remained unchanged or decreased spontaneously. Preemptive entecavir administration was not performed in 1 patient despite HBV reactivation, but the serum ALT level did not increase in any of the 5 patients who showed HBV reactivation during immunosuppressive therapy.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-07
• Study Completion: 2015-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Not provided

Exclusion Criteria

Patients receiving rituximab

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To clarrify the prevalence of HBV-reactivation depending on the types of disease and therapies.