UMIN-CTR Clinical Trial

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
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Research case data
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