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临床试验/JPRN-UMIN000008875
JPRN-UMIN000008875已完成未知

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

Saitama Medical University0 个研究点目标入组 500 人开始时间: 2012年9月7日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
入组人数
500

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
ot applicable 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • Patients receiving rituximab

研究者

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