UMIN-CTR Clinical Trial

Public title

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

Acronym

Verifiing the Impact of Regulatory Alerts

Scientific Title

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

Scientific Title:Acronym

Verifiing the Impact of Regulatory Alerts

Region

Japan

Condition

Rheumatoid arthritis, malignant tumor

Classification by specialty

Medicine in general	Gastroenterology	Hematology and clinical oncology
Clinical immunology	Surgery in general	Gastrointestinal surgery
Hepato-biliary-pancreatic surgery	Vascular surgery	Chest surgery
Endocrine surgery	Breast surgery	Dermatology
Orthopedics	Urology	Radiology
Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

In verification of the effect of the risk minimization activities for a drug, we investigate the possibility of the secondary use of the medical database (DB).

Basic objectives2

Others

Basic objectives -Others

Using MDV's claim DB, this study is intend to investigate whether could be confirm any change in the behavior on the laboratory tests for hepatitis B with the patients treated with an immunosuppressive agent before and after the transmission of the warning letter from PMDA.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

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.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key 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.

Key exclusion criteria

N/A

Target sample size

10000

Name of lead principal investigator

1st name
Middle name
Last name	Jyouji Mochizuki

Organization

Chugai Pharmaceutical Co.Ltd.

Division name

Drug Safety Div.

Zip code

Address

1-1 Nihonbashi-Muromachi 2-chome, Chuouku, Tokyo

TEL

03-3281-6611

Email

mochizukijuj@chugai-pharm.co.jp

Name of contact person

1st name
Middle name
Last name	Yukio Udagawa

Organization

Chugai Pharmaceutical Co.Ltd.

Division name

Drug Safety Div.

Zip code

Address

1-1 Nihonbashi-Muromachi 2-chome, Chuouku, Tokyo

TEL

03-3281-6611

Homepage URL

Email

udagawayko@chugai-pharm.co.jp

Institute

Chugai Pharmaceutical Co.Ltd.

Institute

Department

Personal name

Organization

Chugai Pharmaceutical Co.Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2014

Year

11

Month

07

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

http://rd.springer.com/article/10.1007/s40801-015-0034-5

Number of participants that the trial has enrolled

Results

Data for 9,866 patients in the clinical database were analyzed. After the PMDA alert, the percentage of patients tested for HBV-DNA linearly increased in periods A to D: 4.70% (n=262/5571), 5.78% (n=330/5710), 6.52% (n=398/6101), and 7.59% (n=479/6315). However, no changes were observed in the rates of HBsAg and HBcAb/HBsAb testing (around 50% and 70%, respectively). Overall testing rates appeared to differ depending on disease and drug type.
These findings suggest that the PMDA alert was effective at recommending HBV-DNA testing. This secondary application of clinical databases may be effective for verifying the impact of risk minimization activities.

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2014

Year

09

Month

18

Day

Date of IRB

Anticipated trial start date

2014

Year

09

Month

22

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The MDV medical record database is selected as the most suitable data source for the intended study due to the fact that it contains all necessary data required to achieve the objective of the epidemiological study and to conduct the benefit-risk analysis as planned. The MDV medical record database consists of anonymized patient information collected from hospitals. Data from electronic receipts and Diagnosis Procedure Combination (DPC) files are anonymized at contracting hospitals and sent to MDV for the generation of a database. It contains medical information derived from approximately 7.5 million patients at 147 acute-phase medical institutions participating in the DPC system in Japan as of May 2014. It provides a tool that allows not only the analysis of the number of patients and the amount of drugs prescribed in a specific field of interest, but also a multidimensional analysis based on actual medical treatments, including surgery and examination.

Registered date

2014

Year

11

Month

07

Day

Last modified on

2016

Year

07

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018163