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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031368
Receipt No. R000035755
Scientific Title Association between hepatitis B virus (HBV) reactivation and recurrence of hepatocellular carcinoma (HCC) following direct-acting antiviral (DAA) treatment for hepatitis C.
Date of disclosure of the study information 2018/03/01
Last modified on 2018/02/17

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Basic information
Public title Association between hepatitis B virus
(HBV) reactivation and recurrence of
hepatocellular carcinoma (HCC) following
direct-acting antiviral (DAA) treatment
for hepatitis C.
Acronym Association between hepatitis B virus
(HBV) reactivation and recurrence of
hepatocellular carcinoma (HCC) following
direct-acting antiviral (DAA) treatment
for hepatitis C.
Scientific Title Association between hepatitis B virus
(HBV) reactivation and recurrence of
hepatocellular carcinoma (HCC) following
direct-acting antiviral (DAA) treatment
for hepatitis C.
Scientific Title:Acronym Association between hepatitis B virus
(HBV) reactivation and recurrence of
hepatocellular carcinoma (HCC) following
direct-acting antiviral (DAA) treatment
for hepatitis C.
Region
Japan

Condition
Condition Hepatitis C, Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Hepatitis C virus (HCV) eradication by
DAA treatment is known to induce HBV
reactivation. While DAA treatment may not directly increase the incidence of HCC recurrence, critical recurrence may develop
in some patients due to reduced immune
functions.
Basic objectives2 Others
Basic objectives -Others In the present study, we examined the association between HCC recurrence and changes of HBV markers.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HBs/HBc antibodies and HBV DNA before
and after DAA.
Key secondary outcomes

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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria HBs/HBc antibodies and HBV DNA before and after DAA was measured in our patients
who achieved SVR24.
Key exclusion criteria none.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kouji Joko
Organization Matsuyama Red Cross Hospital
Division name Center for Liver-Biliary-Pancreatic Diseases
Zip code
Address 1, Bunkyo-cho, Matsuyama-shi, EHIME, JAPAN
TEL 089-924-1111
Email koujijoko@matsuyama.jrc.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshie Mashiba
Organization Matsuyama Red Cross Hospital
Division name Center for Liver-Biliary-Pancreatic Diseases
Zip code
Address 1, Bunkyo-cho, Matsuyama-shi, EHIME, JAPAN
TEL 089-924-1111
Homepage URL
Email matoshi@matsuyama.jrc.or.jp

Sponsor
Institute Matsuyama Red Cross Hospital
Institute
Department

Funding Source
Organization Matsuyama Red Cross Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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
2018 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 Completed
Date of protocol fixation
2017 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2017 Year 12 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 Tumor index and HBs/HBc antibody index areculated as follows:
Tumor index= maximum diameter(cm)+number of tumors
Tumor index ratio = tumor index at recurrence after DAA/tumor index at the time of treatment before DAA
HBs antibody ratio= HBs antibody after DAA/HBs antibody before DAA
HBc antibody ratio= HBc antibody after DAA/HBc antibody before DAA

Management information
Registered date
2018 Year 02 Month 19 Day
Last modified on
2018 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035755

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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