Using Clinical Databases to Verify the Impact of Regulatory Agency Alerts in Japan: Hepatitis B Testing Behavior After an Alert Regarding Risk of Viral Reactivation

Using Clinical Databases to Verify the Impact of Regulatory Agency Alerts in Japan: Hepatitis B Testing Behavior After an Alert Regarding Risk of Viral Reactivation - Verifiing the Impact of Regulatory Alerts

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000015628

Enrollment

10000

Registered

2014-11-07

Start date

2014-09-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis, malignant tumor

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The patients who were already administered and newly administered immunosuppressive agent during the periods before and after the transmission of the warning letter. 2. The patients who were newly administered immunosuppressive agent during the periods before and after the transmission of the warning letter.

Exclusion criteria

Exclusion criteria: N/A

Design outcomes

Primary

Measure	Time frame
1. In the patients who were already administered and newly administered an immunosuppressive agent, we estimate the proportion of the number of patients who were measured HBV-DNA test and the frequency of measure in the patients carried out. 2. In the patients who were newly administered an immunosuppressive agent, we estimate the proportion of the number of patients who were measured HBs antigen test before initiation of the administration of an immunosuppressive agent, the proportion of the negative for HBs antigen in the patients measured the test, and the proportion of the number of patients who were measured HBc antibody and/or HBs antibody within the patients of negative for HBs antigen.	—

Measure

Time frame

1. In the patients who were already administered and newly administered an immunosuppressive agent, we estimate the proportion of the number of patients who were measured HBV-DNA test and the frequency of measure in the patients carried out. 2. In the patients who were newly administered an immunosuppressive agent, we estimate the proportion of the number of patients who were measured HBs antigen test before initiation of the administration of an immunosuppressive agent, the proportion of the negative for HBs antigen in the patients measured the test, and the proportion of the number of patients who were measured HBc antibody and/or HBs antibody within the patients of negative for HBs antigen.

—

Countries

Japan

Contacts

Public ContactYukio Udagawa

Chugai Pharmaceutical Co.Ltd. Drug Safety Div.

udagawayko@chugai-pharm.co.jp03-3281-6611

Outcome results