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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000008875
Receipt No. R000010373
Scientific Title Nationwide Long-Term Survey of Hepatitis B Virus Reactivation in Patients Receiving Immunosuppressive Drugs to Establish the Therapeutic Strategy to Prevent Severe Liver Injury.
Date of disclosure of the study information 2012/09/07
Last modified on 2016/03/07

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Basic information
Public title Nationwide Long-Term Survey of Hepatitis B Virus Reactivation in Patients Receiving Immunosuppressive Drugs to Establish the Therapeutic Strategy to Prevent Severe Liver Injury.
Acronym Long-Term Survey of Hepatitis B Virus Reactivation in Patients Receiving Immunosuppressive Drugs
Scientific Title Nationwide Long-Term Survey of Hepatitis B Virus Reactivation in Patients Receiving Immunosuppressive Drugs to Establish the Therapeutic Strategy to Prevent Severe Liver Injury.
Scientific Title:Acronym Long-Term Survey of Hepatitis B Virus Reactivation in Patients Receiving Immunosuppressive Drugs
Region
Japan

Condition
Condition HBV-infected patients
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Clinical immunology
Ophthalmology Dermatology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarrify the significance of the guideline to prevent HBV reactivation in the patients with previous HBV infecdtion, whom immunosuppresive drugs are administrated more than one year.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes To clarrify the prevalence of HBV-reactivation depending on the types of disease and therapies.
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 Patients with previous HBV infection receiving immunosuppresive therapies
Key exclusion criteria Patients receiving rituximab
Target sample size 500

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Mochida
Organization Saitama Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address Morohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
TEL 049-276-1198
Email smochida@saitama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nobuaki Nakayama
Organization Saitama Medical University
Division name Department of Gastroenterology and Hepatology
Zip code
Address Morohongo 38, Moroyama-Machi, Iruma-Gun, Saitama, 350-0495, Japan
TEL 049-276-1198
Homepage URL http://www.saitama-med.ac.jp/uinfo/mnaika3/
Email kgoto@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

Funding Source
Organization Ministry of Health, Wealthy and Labor
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2012 Year 09 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results A total of 289 patients with previously resolved HBV infection, consisting of 200 patients with rheumatoid diseases, 44 patients with skin diseases, 28 patients with intestinal diseases, and 17 patients with ophthalmological diseases, were enrolled. Seventy-two patients were enrolled before the initiation of immunosuppressive therapies, but 217 patients were enrolled after the initiation of immunosuppressive therapy.
Serum HBV-DNA became detectable in 9 patients (3.1%) at a median of 25 months, ranging from 4 to 201 months after the initiation of immunosuppressive therapy, and the levels exceeded 1.3 Log IU/mL in 5 patients (1.7%) .Among these 5 patients with HBV reactivation, the serum HBV-DNA levels were further increased in only 1 patient at 1 month thereafter; in the remaining 4 patients, the serum HBV-DNA level remained unchanged or decreased spontaneously.
Preemptive entecavir administration was not performed in 1 patient despite HBV reactivation, but the serum ALT level did not increase in any of the 5 patients who showed HBV reactivation during immunosuppressive therapy.
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 Main results already published
Date of protocol fixation
2012 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2012 Year 07 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Kaplan-Meier analyses were performed to clarify the increase of cumulative incidences of HBV reactivation during immunosuppressive therapies in previously resolved HBV infection.
Among the 131 patients who received immunosuppressive therapies after enrollment in the other prospective study (UMIN 000002859), the cumulative incidence of HBV reactivation, defined as a serum HBV-DNA level of 1.3 Log IU/mL or more, was 3.2% at 6 months after the initiation of immunosuppressive therapy, while the increase of cumulative incidences after 6 months were relatively small.Thus, a Kaplan-Meier analysis was performed for 420 patients enrolled in both this study and the other study (UMIN 000002859) to clarify the increase of cumulative incidences after 6 months of immunosuppressive therapy, and the percentages were found to be 0% at 12 months and +0.5%, +1.5% and +1.5% at 24, 36, and 48 months, respectively.

Management information
Registered date
2012 Year 09 Month 07 Day
Last modified on
2016 Year 03 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010373

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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