UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy of Pegylated interferon treatment for chronic hepatitis B
Acronym	Efficacy of Pegylated interferon
Scientific Title	Efficacy of Pegylated interferon treatment for chronic hepatitis B
Scientific Title:Acronym	Efficacy of Pegylated interferon
Region	Japan

Condition
Condition	patients with chronic hepatitis B infection
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to assess the efficacy of pegylated interferon treatment for chronic hepatitis B
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	probability of HBV DNA negativity decrease rate of HB surface antigen level decrease rate of HB core-related antigen probability of ALT normalization probability of HBe antigen seroconversion cumulative incidence rate of hepatocellular carcinoma
Key secondary outcomes	improvement of liver fibrosis

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	1)patients with 20 years of age and older 2)HB surface antigen positive for over 6 months 3)patients without cirrhosis 4)baseline hemoglobin over 10 g/dl 5)baseline platelet counts over 90000/microL 6)baseline neutrophil over 1500/microL
Key exclusion criteria	1)pregnant woman 2)co-infection with other hepatitis virus (HCV/HDV/HIV) 3)other liver disease such as autoimmune hepatitis, alcoholic liver disease etc. 4)comorbidity with other severe disease or immune dificiency 5)severe depression or other severe mental disease 6)contraindication for interferon treatment
Target sample size	100

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	Gastroenterology and Hepatology
Zip code	565-0871
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	81-6-6879-3621
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	Gastroenterology and Hepatology
Zip code	565-0871
Address	2-2, Yamadaoka, Suita, Osaka, Japan
TEL	81-6-6879-3621
Homepage URL
Email	ryo726@gh.med.osaka-u.ac.jp

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

Funding Source
Organization	Grant-in-Aid for Research on Hepatitis from Ministry of Health Labour and Welfare of Japan, and Scientific Research from the Ministry of Education, Science, and Culture of Japan
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2015 Year 08 Month 01 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	Enrolling by invitation
Date of protocol fixation	2015 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date	2015 Year 08 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	To assess the efficacy of pegylated interferon in patients infected with hepatitis B virus. To investigate the relative factors with antiviral effect and suppressive effect of hepatocellular carcinoma.

Management information
Registered date	2015 Year 07 Month 21 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=R000021253