UMIN-CTR Clinical Trial

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

HBV-infected patients

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Clinical immunology
Ophthalmology	Dermatology

Classification by malignancy

Others

Genomic information

YES

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

Primary outcomes

To clarrify the prevalence of HBV-reactivation depending on the types of disease and therapies.

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

Patients with previous HBV infection receiving immunosuppresive therapies

Key exclusion criteria

Patients receiving rituximab

Target sample size

500

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

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

Institute

Saitama Medical University

Institute

Department

Personal name

Organization

Ministry of Health, Wealthy and Labor

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan

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

2012

Year

09

Month

07

Day

URL releasing protocol

Publication of results

Published

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

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 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.

Registered date

2012

Year

09

Month

07

Day

Last modified on

2016

Year

03

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010373