HBV Reactivation in Anti CD20 Treatment

NCT05768061 | Unknown DMC

• 1 other identifier: 0122-21-COM2
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B

Keywords

anti CD20; Rituximab; HBV- hepatitis B virus

Outcome Measures

Primary Outcomes (1)

• HBV DNA in the blood.

  Reactivation of HBV is defined when one of these three conditions exist: 1. when Participant has An increase of more than log1 in the concentration of HBV DNA in the blood. 2. when Participant has A positive HBV DNA result compared to a negative result before starting treatment with Rituximab (anti CD20). 3. 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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The population of subjects who received anti-CD20 drugs as a treatment for a variety of diseases between the years 2000 to 2021, within Clalit Health care record database.

You may qualify if:

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

You may not qualify if:

• healthy subjects.
• subjects under the age 18.
• subjects who did not receive anti CD20

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

HaEmek Medical Center

Afula, Northern District, 1834111, Israel

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Rawi Hazzan, MD

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of liver unit

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 14, 2023
• Study Start: December 16, 2021
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 16, 2023

Record last verified: 2023-03

Locations

IL (1)