HBV Reactivation in Anti CD20 Treatment

Hepatitis B Clinical Trial

Official title:

HBV Reactivation in Anti CD20 Treatment

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05768061
• Other study ID #: 0122-21-COM2
• Status: Active, not recruiting
• Start date: December 16, 2021
• Est. completion date: December 2023

Study information

• Verified date: March 2023
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5000
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis B

Locations

Country	Name	City	State
Israel	HaEmek Medical Center	Afula	Tsafon

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HBV DNA in the blood.	Reactivation of HBV is defined when one of these three conditions exist: when Participant has An increase of more than log1 in the concentration of HBV DNA in the blood.; when Participant has A positive HBV DNA result compared to a negative result before starting treatment with Rituximab (anti CD20).; when Participant has HDV (hepatitis D virus) DNA result greater than 20000 IU/mL in the absence of a test before starting treatment; The HBV DNA concentration at the beginning of the treatment was defined in the time period between six months before the start of the treatment and 30 days after the start of the treatment.	about 10 minutes per blood test.