UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	PegIFNalpha-2a treatment added-on entecavir for HBeAg and HBV DNA negative patients treated with long-term entecavir
Title of the study (Brief title)	PegIFNalpha-2a treatment added-on entecavir
Region	Japan

Condition
Condition	chronic hepatitis B
Classification by specialty	Hepato-biliary-pancreatic medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The reduction of HBsAg levels during peg interferon added on entecavir
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The reduction of HBsAg and the number of patients who achieve >0.5 log U/mL at 48 weeks after randomization
Key secondary outcomes	1) The change of HBsAg levels at 1Y, 2Y and 3Y after peg interferon add-on treatment 2) Clearance rates of HBsAg and rates of < 100 U/mL or <1000 U/mL

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Peg interferon therapy added-on entecavir
Interventions/Control_2	Entecavir mono therapy
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	Entecavir-treated (more than 1 year) CHB patients met the following criteria, 1) HBsAg-positive 2) HBeAg-negative 3) HBV DNA-undetectable (continuous undetection for more than 1 year)
Key exclusion criteria	1) Patients receiving Chinese herb (sho-sai-ko-to) 2) Patients with history of interstitial pneumonia 3) Patients with auto immune hepatitis 4) Patients with hypersensitivity to interferon 5) Patients with hypersensitivity to biological agents 6) Patients with neutropenia (<1500/mm3), thrombocytopenia (<90000/mm3), or anemia (Hb<12g/dL) 7) Cirrhotic patients 8) Patients with history of HCC 9) Doctors consider inadequate
Target sample size	100

Research contact person
Name of lead principal investigator	Hiromitsu Kumada
Organization	Toranomon Hospital
Division name	Hepatology
Address	1-3-1 Kajigaya Takatsu-ku Kawasaki Kanagawa
TEL	044-877-5111
Email	kumahiro@toranomon.gr.jp

Public contact
Name of contact person	Tetsuya Hosaka
Organization	Toranomon Hospital
Division name	Hepatology
Address	1-3-1 Kajigaya Takatsu-ku Kawasaki Kanagawa
TEL	044-877-5111
Homepage URL
Email	hosa-p@toranomon.gr.jp

Sponsor
Institute	Toranomon Hospital
Institute
Department

Funding Source
Organization	Toranomon 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	札幌厚生病院（北海道）

Other administrative information
Date of disclosure of the study information	2013 Year 12 Month 05 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 11 Month 18 Day
Anticipated trial start date	2013 Year 12 Month 09 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

Management information
Registered date	2013 Year 12 Month 01 Day
Last modified on	2017 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000014573