NCT05768061

HBV Reactivation in Anti CD20 Treatment

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 5,000 (estimated)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to test and describe the frequency of hepatitis B virus reactivation in patients who received anti-CD20 drugs for a wide variety of autoimmune and hemato-oncological diseases in order to find out whether a group of patients from a certain field was more sensitive to treatment in this respect than patients from other fields.

Detailed description

Hepatitis B virus(HBV) is the most common chronic virus worldwide. it causes an infection of the liver (hepatitis B) and it is transmitted from person to person through contact with virus-contaminated blood, through sexual intercourse, and vertically from mother to fetus. Anti CD20 drug or Rituximab is an anti-CD20 monoclonal antibody on the surface of B lymphocytes, which induces cell death (apoptosis) and thus causes depletion. The main side effects of rituximab are infectious and hypersensitivity reactions. It can also increase the chance of hepatitis B reactivation to the point of acute hepatitis. The information for this retrospective study will be collected from clalit health care's databases. The patients will be sorted according to the indications for which the treatment with anti-CD20 drugs was given in order to see the differences in the response to the drug in different groups of patient

Conditions

• Hepatitis B

Timeline

• Start date: 2021-12-16
• Primary completion: 2023-12-01
• Completion: 2023-12-01
• First posted: 2023-03-14
• Last updated: 2023-03-16

Locations

1 site across 1 country: Israel