UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of efficacy and safety of PEG-IFN alpha-2a for the treatment of chronic hepatitis B.
Title of the study (Brief title)	PEG-IFN alpha-2a therapy for 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	To examine the efficacy and safety of PEG-IFN alpha 2a for the treatment of chronic hepatitis B.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	[HBeAg-positive chronic hepatitis B] Efficacy assessed after 24 weeks of follow up for 1)HBeAg seroconversion 2)the normalization of alanine aminotransferase levels (below 30IU/L), and the suppression of HBV DNA levels to below 5.0Log copies/ml [HBeAg-negative chronic hepatitis B] Efficacy assessed after 24 weeks of follow up for 1)the suppression of HBV DNA levels to below 4.3Log copies/ml 2)the normalization of alanine aminotransferase levels (below 40IU/L) 3)the normalization of alanine aminotransferase levels (below 30IU/L), and the suppression of HBV DNA levels to below 4.0Log copies/ml
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	PEG-IFN alpha-2a for the treatment of chronic hepatitis B
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1.Patient diagnosed as chronic hepatitis B 2.Before beginning therapy, patients were eligible if they had . a neutrophil count of more than 1500/microliter . a platelet count of more than 90,000/microliter . a hemoglobin count of more than 12g/dl . Patient who obtains agreement for participation in present study
Key exclusion criteria	1.Patient who is administering the sho-sai-ko-to 2.A patient with the previous history of interstitial pneumonia 3.Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis 4.Patient who has previous history of hypersensitivity for element of PEG-IFN alpha-2a or other IFNs 5.Patient who has previous history of hypersensitivity for biological products such as vaccines 6.Patient with cirrhosis, liver failure, and liver carcinoma 7.Hepatic encephalopathy, an esophageal varix, a patient with abdominal dropsy, or a patient with these previous history 8.A patient with autoimmune diseases (hemolytic anemia, chronic ulcerative colitis, rheumatoid arthritis, etc.), or a patient with these anamneses 9. Patient who has heart disease difficult to control (cardiac infarction, cardiac failure, and arrhythmia, etc.) 10. Patient who exists in serious state of mental disease of serious depression, thought of suicide or suicide plan, etc. or with these history 11. The patient of uncontrollable hypertension 12. A patient with the past of apoplexy (cerebral infarction, cerebral hemorrhage, subarachnoid bleeding, transient ischemic attack) 13. Pregnant woman or woman who has possibility of pregnancy or woman while suckling 14. Additionally, patient judged by doctor that participation in this study is improper
Target sample size	100

Research contact person
Name of lead principal investigator	Takeshi Azuma
Organization	Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name	Gastroenterology
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL
Email

Public contact
Name of contact person	Yoshihiko Yano
Organization	Kobe University Hospital
Division name	Gastroenterology
Address	7-5-2, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	078-382-6305
Homepage URL
Email	yanoyo@med.kobe-u.ac.jp

Sponsor
Institute	Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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	2012 Year 01 Month 04 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2011 Year 11 Month 01 Day
Anticipated trial start date	2011 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2011 Year 11 Month 01 Day
Last modified on	2017 Year 11 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007863