UMIN-CTR Clinical Trial

Basic information
Public title	A multicenter open-label randomized controlled trial comparing interferon-nucleoside/nucleotide analogues add-on therapy with interferon-nucleoside/nucleotide analogues sequential therapy for chronic hepatitis B.
Acronym	Interferon-nucleoside/nucleotide analogues add-on and sequential therapy for chronic hepatitis B: a randomized controlled trial
Scientific Title	A multicenter open-label randomized controlled trial comparing interferon-nucleoside/nucleotide analogues add-on therapy with interferon-nucleoside/nucleotide analogues sequential therapy for chronic hepatitis B.
Scientific Title:Acronym	Interferon-nucleoside/nucleotide analogues add-on and sequential therapy for chronic hepatitis B: a randomized controlled trial
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to clarify whether peginterferon alpha-2a-nucleoside/nucleotide analogues add-on therapy is superior to peginterferon alpha-2a-nucleoside/nucleotide analogues sequential therapy in chronic hepatitis B patients who currently take nucleoside/nucleotide analogues.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	The number of patients who achieve > 0.5 logU/ml reduction of HBsAg after 24 and 48 weeks.
Key secondary outcomes	(1)Change of ALT (2)Change of HBeAg (3)HBV-specific immunological reactions

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Peginterferon-nucleoside/nucleotide analogues sequential therapy arm:For patients who take nucleoside/nucleotide analogues orally, 90 to 180ug of PEG-IFN alpha-2a is administered subcutaneously once a week for 48 weeks. Nucleoside/nucleotide analogues will be quitted 4 weeks after starting PEG-IFN alpha-2a.
Interventions/Control_2	Peginterferon-nucleoside/nucleotide analogues add-on therapy arm:For patients who take nucleoside/nucleotide analogues orally, 90 to 180ug of PEG-IFN alpha-2a is administered subcutaneously once a week for 48 weeks. Nucleoside/nucleotide analogues will be continued through 48 weeks.
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	(1) Chronic hepatitis B patients who take nucleoside/nucleotide analogues at least for three months. (2) Chronic hepatitis patients without advanced liver fibrosis (up tp F2). (3)　Patients who well understand the risk of exacerbation of hepatitis after stopping nucleoside/nucleotide analogues and can be closely watched.
Key exclusion criteria	(1)The patients who are prescribed with Sho-saiko-toh. (2)The patients who had or have interstitial pneumonia. (3)The patients with autoimmune hepatitis. (4)The patients who have an allergy against interferon and other medications in the study. (5)The patients who have allergy against vaccine or other biologics. (6)The patients with a severe mental disease such as depression, a suicide consideration, or suicide project, or the past history of such conditions. (7)The patients with liver cirrhosis or severe hepatic diseases. (8)The patients with untreated hepatic cancers. (9)The patients who were judged inappropriate for the study by the doctor.
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Shinichi Asabe
Organization	Saitama Medical Center, Jichi Medical University
Division name	Department of Gastroenterology
Zip code
Address	1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL	048-647-2111
Email	jmukanzo@gmail.com

Public contact
1st name of contact person	1st name Middle name Last name Shinichi Asabe
Organization	Saitama Medical Center, Jichi Medical University
Division name	Department of Gastroenterology
Zip code
Address	1-847 Amanuma-cho, Omiya-ku, Saitama-shi, Saitama
TEL	048-647-2111
Homepage URL
Email	jmukanzo@gmail.com

Sponsor
Institute	Department of Gastroenterology,Saitama Medical Center, Jichi Medical University
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization	none

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	2016 Year 04 Month 06 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	Terminated
Date of protocol fixation	2016 Year 04 Month 04 Day
Date of IRB	2016 Year 04 Month 01 Day
Anticipated trial start date	2016 Year 04 Month 04 Day
Last follow-up date	2018 Year 12 Month 31 Day
Date of closure to data entry	2018 Year 12 Month 31 Day
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 04 Month 04 Day
Last modified on	2019 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025076