UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024019 |
|---|---|
| Receipt number | R000027653 |
| Scientific Title | Prospective study of HBV reactivation in patients with chronic HCV infection, treated with direct acting antivirals |
| Date of disclosure of the study information | 2017/12/31 |
| Last modified on | 2019/09/26 20:03:45 |
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Basic information
Public title
Prospective study of HBV reactivation in patients with chronic HCV infection, treated with direct acting antivirals
Acronym
HBV reactivation survey in DAA therapy
Scientific Title
Prospective study of HBV reactivation in patients with chronic HCV infection, treated with direct acting antivirals
Scientific Title:Acronym
HBV reactivation survey in DAA therapy
Region
| Japan |
Condition
Condition
Chronic liver disease with HCV
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the prevalence of HBV reactivation in patients with chronic liver diseases HCV, who are treated with interferon-free direct acting antivirals.
Basic objectives2
Others
Basic objectives -Others
To elucidate the host and viral genetic populations related to HBV reactivation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of HBV reactivation
Key secondary outcomes
Treatment of HBV reactivation
Human factors associated with HBV reactvation
Viral factors associated with HBV reactivation
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients treated with DAA therapy.
and
With more than one of HBV serum markers; HBsAg, anti-HBc, anti-HBs.
Key exclusion criteria
Negative for all of HBV serum markers; HBsAg, anti-HBc, anti-HBs.
Patients who continue the other viral therapy.
Patients cannot be checked regularly.
Less than 15 years old.
Doctor recognize a patient unsuitable to enroll the study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | AKIHIRO |
| Middle name | |
| Last name | TAMORI |
Organization
Osaka City University Graduate School of Medicine
Division name
Hepatology
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-2292
atamori@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | TAMORI |
Organization
Osaka City University Graduate School of Medicine
Division name
Hepatology
Zip code
5458585
Address
1-4-3, Asahimachi, Abeno-ku, Osaka 545-8585, JAPAN
TEL
06-6645-2292
Homepage URL
atamori@med.osaka-cu.ac.jp
Sponsor or person
Institute
Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Global Health and Medicine, Kohnodai Hospital
Hyogo College of Medicine
National Hospital Organization, Nagasaki Medical Center
Kagawa University
Osaka City General Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Osaka City UNiversity Graduate Scool of Medicine
Address
1-5-7, Asahimachi, Abeno-ku, Osaka 545-8586, JAPAN
Tel
06-6645-3457
ethics@med.osaka-cu.ac.jp
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
| 2017 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
Journal of Viral Hepatitis 2018 25 608
Number of participants that the trial has enrolled
790
Results
HBV reactivation occurred in 3 of 22 patients co-infected with HBV and HCV during anti-HCV therapy. On the other hand, in only one patient with resolved HBV infection, HBV DNA was detected during anti-HCV therapy, Hepatitis flare did not occur in patients with HBV reactivation.
Results date posted
| 2019 | Year | 09 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Among HCV infected patients undergone anti-HCV therapy, HBV co-infected or past HBV infected patients
Participant flow
HBV DNA monitoring during anti-HCV therapy; at baseline, at the end of treatment, and at 12 week after the therapy.
Adverse events
None
Outcome measures
It is necessary to care HBV reactivation in patients co-infected with HBV and HCV during anti-HCV therapy.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2016 | Year | 08 | Month | 30 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who are positive for HBsAg, anti-HBc, or anti-HBs are enrolled to the study. HBV DNA should be examines before DAA therapy. Next, HBV DNA is monitored during therapy, and at 12 the week from end of therapy.
HBV reactivation is defined; 1 log elevation of HBV DNA compare to HBV DNA before therapy. Tuned to be positive for HBV DNA during or after therapy.
Management information
Registered date
| 2016 | Year | 09 | Month | 12 | Day |
Last modified on
| 2019 | Year | 09 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027653
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