UMIN-CTR Clinical Trial

Basic information
Public title	Usefulness of Add-on Therapy of Pegylated Interferon alfa2a with Nucleoside/nucleotide Analog Treatment for Patients with Hepatitis B Virus Infection
Acronym	Add-on therapy of PegIFN-alfa2a with NA treatment
Scientific Title	Usefulness of Add-on Therapy of Pegylated Interferon alfa2a with Nucleoside/nucleotide Analog Treatment for Patients with Hepatitis B Virus Infection
Scientific Title:Acronym	Add-on therapy of PegIFN-alfa2a with NA treatment
Region	Japan

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

Objectives
Narrative objectives1	To improve the success rate of discontinuation of nucleoside/nucleotide analog by add-on therapy with pegylated interferon aifa-2a with nucleotide analog treatment for patients with HBV infection.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The primary endpoint is achievement rate of discontinuation of NA until 5 years after add-on therapy.
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	PegIFN alfa-2a (Pegasys) once 90 or 180 micrograms, administered 48 times per week
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	HBe antigen-negative and anti-HBc positive serum HBV-DNA levels were undetective; under 2.1 log copies/ml (20 IU/ml) more than 80 IU/mL of HBs antigen levels or more than 3.0 log U/ml of HBcrAg levels
Key exclusion criteria	Cirrhosis HCC During pregnancy Mental illness merger Minor
Target sample size	50

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Mochida
Organization	Saitama Medical University
Division name	Department of Gastroenterology & Hepatology
Zip code	3500495
Address	38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
TEL	+81(0)49-276-1198
Email	smochida@saitama-med.ac.jp

Public contact
Name of contact person	1st name Satoshi Middle name Last name Mochida
Organization	Saitama Medical University
Division name	Department of Gastroenterology & Hepatology
Zip code	3500495
Address	38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
TEL	+81(0)49-276-1198
Homepage URL
Email	smochida@saitama-med.ac.jp

Sponsor
Institute	Saitama Medical University, Department of Gastroenterology & Hepatology
Institute
Department

Funding Source
Organization	Saitama Medical University, Department of Gastroenterology & Hepatology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Institutional Review Board of Saitama Medical University Hospital
Address	38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
Tel	049-276-1354
Email	hirb@saitama-med.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	2018 Year 05 Month 25 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	26
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	No longer recruiting
Date of protocol fixation	2016 Year 06 Month 27 Day
Date of IRB	2016 Year 08 Month 01 Day
Anticipated trial start date	2016 Year 08 Month 01 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 05 Month 25 Day
Last modified on	2021 Year 05 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026223