UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031368 |
|---|---|
| Receipt number | 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 19:38:28 |
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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
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
matoshi@matsuyama.jrc.or.jp
Sponsor or person
Institute
Matsuyama Red Cross Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035755
