UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015628
Receipt No. R000018163
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
Date of disclosure of the study information 2014/11/07
Last modified on 2016/07/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
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
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

Objectives
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

Assessment
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

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Chugai Pharmaceutical Co.Ltd.
Institute
Department

Funding Source
Organization Chugai Pharmaceutical Co.Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2014 Year 11 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
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

Progress
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
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.

Management information
Registered date
2014 Year 11 Month 07 Day
Last modified on
2016 Year 07 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018163

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.