UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Association between hepatitis B virus (HBV) reactivation and recurrence of hepatocellular carcinoma (HCC) following direct-acting antiviral (DAA) treatment for hepatitis C.
Title of the study (Brief title)	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	Kouji Joko
Organization	Matsuyama Red Cross Hospital
Division name	Center for Liver-Biliary-Pancreatic Diseases
Address	1, Bunkyo-cho, Matsuyama-shi, EHIME, JAPAN
TEL	089-924-1111
Email	koujijoko@matsuyama.jrc.or.jp

Public contact
Name of contact person	Toshie Mashiba
Organization	Matsuyama Red Cross Hospital
Division name	Center for Liver-Biliary-Pancreatic Diseases
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 11 Month 15 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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