UMIN-CTR Clinical Trial

Basic information
Public title	Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B
Acronym	Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B
Scientific Title	Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B
Scientific Title:Acronym	Effect of switching therapy from nucleos(t)ide analogue to pegylated-interferon in patients with chronic hepatitis B
Region	Japan

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

Objectives
Narrative objectives1	Nucleos(t)ide analogues (NAs) have been used generally for patients with chronic hepatitis B, but they have no effect on intrahepatic HBV (cccDNA), leading to recurrence of hepatitis after cessation of NAs. Moreover, little is known about the suppressive effect of NA treatment for developing hepatocellular carcinoma (HCC). On the other hand, interferon has a weak effect on HBV reproduction inhibition, but has immunomodulatory effects, with antiviral effects persisting after completion of administration. The aim of this study is to investigate the antiviral effect and suppressive effect on incidence of HCC in patients with chronic hepatitis B by switching therapy from NAs to pegylated interferon.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	decline rate of HB surface antigen, loss of HB surface antigen decline rate of HB core-related antigen suppression of HBV DNA (< 4 log copies/mL) ALT normalization HBe antigen seroconversion (among patients with HBe antigen) at 24 and 48 weeks after completing pegylated interferon treatment
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	drug: PegIFN alfa 2a duration: PegIFN alfa 2a and nucleos(t)ide analogue combination therapy for 12 weeks and monotherapy of PegIFN alfa 2a for 36 weeks dose: PegIFN alfa 2a 90-180mcg s.c. weekly
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	patients with chronic hepatitis B treated with nucleos(t)ide analogue and HBV DNA < 4 log copies/mL for more than 1 year
Key exclusion criteria	under age of 20 significant liver fibrosis (F3-) coinfection with HCV / HDV / HIV coexistence with other chronic liver disease pregnant or breast-feeding women contraindication to scheduled drugs patients found to be inadequate by their doctors
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Tetsuo Middle name Last name Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	565-0871
Address	2-2, Yamadaoka, Suita City, Osaka
TEL	06-6879-3621
Email	takehara@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	1st name Ryoko Middle name Last name Yamada
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code	565-0871
Address	2-2, Yamadaoka, Suita City, Osaka
TEL	06-6879-3621
Homepage URL
Email	ryo726@gh.med.osaka-u.ac.jp

Sponsor
Institute	Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Osaka University Clinical Research Review Committee
Address	2-2, Yamadaoka, Suita, Osaka
Tel	06-6210-8289
Email	rinri@hp-crc.med.osaka-u.ac.jp

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	2013 Year 11 Month 27 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	Open public recruiting
Date of protocol fixation	2013 Year 04 Month 11 Day
Date of IRB
Anticipated trial start date	2013 Year 05 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

Management information
Registered date	2013 Year 11 Month 27 Day
Last modified on	2019 Year 08 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011457