HBV Reactivation in Anti CD20 Treatment

NCT ID: NCT05768061

Last Updated: 2023-03-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-16

Study Completion Date

2023-12-31

Brief Summary

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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

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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

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Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* subjects (men and women) of age 18 and above, who received anti-CD20 (Rituximab) drugs as a treatment for a variety of diseases .

Exclusion Criteria

* healthy subjects.
* subjects under the age 18.
* subjects who did not receive anti CD20
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Rawi Hazzan

Head of liver unit

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rawi Hazzan, MD

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

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HaEmek Medical Center

Afula, Northern District, Israel

Site Status

Countries

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Israel

Other Identifiers

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0122-21-COM2

Identifier Type: -

Identifier Source: org_study_id

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