UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024019
Receipt No. 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 (Ver. 6)

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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
Email 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
Email atamori@med.osaka-cu.ac.jp

Sponsor
Institute Osaka City University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027653