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

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 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


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

Value
https://center6.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