UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002859 |
|---|---|
| Receipt number | 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 18:12:24 |
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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
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
nobunaka@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003491
