UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The risk of HBV reactivation by HCV patients undergoing DAA treatment
Title of the study (Brief title)	Reactivation of HBV during DAA treatment
Region	Japan

Condition
Condition	Chronic hepatitis C
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the risk of HBV reactivation during or after treatment with DAA for HCV.
Basic objectives2	Others
Basic objectives -Others	To examine the relation between the longitudinal titer of anti-HBs and the reactivation of HBV.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The rate of development of HBV reactivation
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	Eligible patients were aged 20 years and older with confirmed chronic HCV infection.
Key exclusion criteria	Exclusion criteria included (1) decompensated cirrhosis with Child-Pugh B or C, (2) prior experience of anti-HBV treatment with IFN or nucleos(t)ide analogue, and (3) under treatment with immunosuppressive agents or chemotherapy.
Target sample size	200

Research contact person
Name of lead principal investigator	Norihiro Furusyo
Organization	Kyushu University Hospital
Division name	Department of General Internal Medicine
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5909
Email	furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person	Eiichi Ogawa
Organization	Kyushu University Hospital
Division name	Department of General Internal Medicine
Address	3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5909
Homepage URL
Email	eogawa@gim.med.kyushu-u.ac.jp

Sponsor
Institute	Kyushu University
Institute
Department

Funding Source
Organization	None
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	2017 Year 01 Month 27 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 03 Day
Anticipated trial start date	2015 Year 08 Month 03 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	Published
URL releasing results
Results
Other related information	Retrospective cohort study

Management information
Registered date	2017 Year 01 Month 27 Day
Last modified on	2017 Year 07 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029748