Viewing Study NCT05768061



Ignite Creation Date: 2024-05-06 @ 6:43 PM
Last Modification Date: 2024-10-26 @ 2:53 PM
Study NCT ID: NCT05768061
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2023-03-16
First Post: 2023-03-02

Brief Title: HBV Reactivation in Anti CD20 Treatment
Sponsor: HaEmek Medical Center Israel
Organization: HaEmek Medical Center Israel

Study Overview

Official Title: HBV Reactivation in Anti CD20 Treatment
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2023-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief 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 virusHBV 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 cares 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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None