UMIN-CTR Clinical Trial

Basic information
Public title	The effectiveness of peginterferon -alpha2a and the entecavir combination therapy for the chronic hepatitis B patient
Acronym	The effectiveness of peginterferon and the entecavir combination therapy
Scientific Title	The effectiveness of peginterferon -alpha2a and the entecavir combination therapy for the chronic hepatitis B patient
Scientific Title:Acronym	The effectiveness of peginterferon and the entecavir combination therapy
Region	Japan

Condition
Condition	Chronic Hepatitis B
Classification by specialty	Hepato-biliary-pancreatic medicine Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of the present study is to eavaluate the effectiveness of peginterferon -alpha2a and the entecavir combination therapy for the chronic hepatitis B patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To measure the primary and secondary endpoint regarding cases performed the entecavir and peginterferon -alpha2a combination therapy
Key secondary outcomes

Base
Study type

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	PEG-Interferon-alpha2a + Entecavir
Interventions/Control_2	Entecavir
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	80 years-old >
Gender	Male and Female
Key inclusion criteria	*Genotype C, chronic hepatitis B patients *Written informed consent
Key exclusion criteria	*Under 20 years-old *Patients with the past of other IFN and nucleotide analog preparation dosage within the past one year *Patients with a history of the past of hypersensitivity for PEG-IFN-alpha2a or other IFN preparation *Patients with a history of the past of hypersensitivity for biological preparation such as vaccine *Patients with a history of the past of hypersensitivity for an ingredient of Entecavir *Pregnant or lactating patients *Other hepatitis patients like HCV/HDV/HIV *Other chronic liver diseases (autoimmune hepatitis, alcoholic hepatitis, and so on) *Failure of other organs and immunodeficiency patients *Patients with a history or in the presence of severe psychotic depression or other severe psychotic diseases patients *Inappropriate for this study patients
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Middle name Last name Naoshi Nishida
Organization	Kinki University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL	072-366-0221
Email	naoshi@med.kindai.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Satoru Hagiwara
Organization	Kinki University School of Medicine
Division name	Department of Gastroenterology and Hepatology
Zip code
Address	377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL	072-366-0221
Homepage URL
Email	hagi-318@hotmail.co.jp

Sponsor
Institute	Kinki University School of Medicine
Institute
Department

Funding Source
Organization	not applicable
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
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	2015 Year 01 Month 20 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	Completed
Date of protocol fixation	2014 Year 05 Month 29 Day
Date of IRB	2014 Year 05 Month 29 Day
Anticipated trial start date	2015 Year 01 Month 20 Day
Last follow-up date	2019 Year 05 Month 28 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2015 Year 01 Month 20 Day
Last modified on	2021 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000018814