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Recruitment status Main results already published
Unique ID issued by UMIN UMIN000002859
Receipt No. R000003491
Scientific Title Nationwide Survey of Hepatitis B Virus Reactivation in Patients Receiving Immunosuppressive and/or Anticancer Drugs to Establish the Therapeutic Strategy to Prevent Severe Liver Injury.
Date of disclosure of the study information 2009/12/08
Last modified on 2016/02/02

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Basic information
Public title Nationwide Survey of Hepatitis B Virus Reactivation in Patients Receiving Immunosuppressive and/or Anticancer Drugs to Establish the Therapeutic Strategy to Prevent Severe Liver Injury.
Acronym HBV Reactivation through Immunosuppressive and/or Anti-cancer Therapies
Scientific Title Nationwide Survey of Hepatitis B Virus Reactivation in Patients Receiving Immunosuppressive and/or Anticancer Drugs to Establish the Therapeutic Strategy to Prevent Severe Liver Injury.
Scientific Title:Acronym HBV Reactivation through Immunosuppressive and/or Anti-cancer Therapies
Region
Japan

Condition
Condition HBV carriers and HBV-infected patients
Classification by specialty
Hepato-biliary-pancreatic medicine Hematology and clinical oncology Nephrology
Clinical immunology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarrify the significance of the guideline to prevent HBV re-activation in HBV carriers and the patients with previous HBV infection, in whom immunosuppressive and/or anti-cancer drugs are adminstrated.
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 re-activation depending on the types of diseases and therapies
Key secondary outcomes To clariffy the efficacy of entecavir on development of liver infury due to HBV re-activation.

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 HBV carriers and the patients with previous HBV infection receiving immunosuppressive and/or anti-cancer drugs
Key exclusion criteria The patients receiving rituximab.
Target sample size 530

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi MOCHIDA
Organization Saitama Medical University
Division name Gastroenterology & Hepatology
Zip code
Address 38 Morohongo, Moroyama-cho, Iruma-gun 350-0495, Saitama, 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 Gastroenterology & Hepatology
Zip code
Address 38 Morohongo, Moroyama-cho, Iruma-gun 350-0495, Saitama, Japan
TEL 049-276-1198
Homepage URL
Email nobunaka@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
2009 Year 12 Month 08 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 325 patients were enrolled; 36 patients (11.1%) were positive for serum HBs-antigen, while 289 patients (88.9%) were negative for serum HBs-antigen, but positive for serum anti-HBc and/or anti-HBs antibodies.
 In 36 HBV carriers, preemptive entecavir administration was done before treatment. Consequently, none of these patients developed an elevated serum ALT level.
 In 289 patients with previously resolved HBV infection, the serum HBV-DNA levels were less than 1.3 Log IU/mL at baseline in all the patients, but were qualitatively detectable in 6 patients (2.1%). Serum HBV-DNA became detectable in 20 patients (6.9%) following the initiation of therapy. Among these patients, the serum HBV-DNA levels increased to 1.3 Log IU/mL or more in 11 patients (3.8%).
 Among the 11 patients with serum HBV-DNA levels of 1.3 Log IU/mL or more, entecavir (0.5 mg/day) was administered immediately after the diagnosis of HBV reactivation in 10 patients; consequently, none of these patients developed an elevated serum ALT level. In the remaining 1 patient, serum HBV-DNA level increased to 1.5 Log IU/mL at 34 months, but was decreased to less than 1.3 Log IU/mL at 1 month thereafter, so preemptive entecavir administration was not done.

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
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A total of 36 HBV carriers, consisting of 9 patients in Hematology, 14 patients in Oncology, 11 patients in Rheumatology, and 2 patients in Nephrology , were enrolled. While, 289 patients with previously resolved HBV infection, consisting of 122 patients in Hematology, 36 patients in Oncology, 120 patients in Rheumatology, and 11 patients in Nephrology , were enrolled.
The median observation period for patients receiving immunosuppressive therapies in Rheumatology and Nephrology was 40 months, ranging from 1 to 62 months, while that for patients receiving antineoplastic chemotherapies in Hematology and Oncology was 14 months, ranging from 1 to 55 months.

Management information
Registered date
2009 Year 12 Month 08 Day
Last modified on
2016 Year 02 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003491

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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