UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of the nucleoside analog-PEG-IFN alpha 2a sequential therapy for Drug Free
Title of the study (Brief title)	Examination of the nucleoside analog-PEG-IFN alpha 2a sequential therapy for Drug Free
Region	Japan

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

Objectives
Narrative objectives1	To examine the efficacy and safety of nucleoside analog-PEG-IFN alpha 2a sequential therapy for the chronic hepatitis B.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	[HBeAg-positive chronic hepatitis B] This study had two predetermined primary measures of efficacy assessed after 24 weeks of follow up for 1) HBe 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] the normalization of alanine aminotransferase levels (below 30IU/L) and the suppression of HBV DNA levels to below 4.0Log copies/ml after 24 weeks of follow up
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	48 weeks of PEG-IFN alpha 2a treatment
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 with chronic hepatitis B treated with nucleoside analog, just before the trial, HBV DNA less than 2.1 log copies/mL for less than 1 years 2.Patient diagnosed as chronic hepatitis B before PEG-IFN alpha 2a medication, 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 10g/dl 3. The patient in which a liver biopsy is carried out before PEG-IFN alpha 2a medication in principle, and the result is not F4 4. Patients were not eligible if they had a HBs Ag count of more than 3.0 log copies /mL, and HBcrAg count of more than 4.0 log copies /mL in principle 5. Patients who understand fully the contents of the study and obtain agreement with documents for participation in present study by own free will
Key exclusion criteria	1. The patient who has the resistant to nucleic acid analog, such as Lamivudine and Entecavir 2. Severe state of liver damage (the patient who conflicts with two items or more,total bilirubin is more than 2.0 mg/dl, prothrombin time is less than 70 %, and albumin is less than 3.6 g/dl) 3. Other chronic liver disease patients such as autoimmune hepatitis or alcoholic hepatitis 4. Severe state of complication, especially, patients were not eligible if they kept the function of bone marrow, kidney, heart, or respiration 5. Pregnant woman or woman who has possibility of pregnancy or woman while suckling 6. Patient who is administering the sho-sai-ko-to 7. A patient with the previous history of interstitial pneumonia 8. Patient who has previous history of hypersensitivity for element of PEG-IFN alpha 2a or other IFNs 9. Patient who has previous history of hypersensitivity for biological products such as vaccines 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. 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	Divison of Gastroenterology
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	0783826305
Email

Public contact
Name of contact person	Yoshihiko Yano
Organization	Department of Internal Medicine, Kobe University Graduate School of Medicine
Division name	Divison of Gastroenterology
Address	7-5-1, Kusunoki-cho, Chuo-ku, Kobe, Japan
TEL	0783826305
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	None
Organization
Division
Category of Funding Organization	Self funding
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 04 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2012 Year 03 Month 14 Day
Anticipated trial start date	2012 Year 03 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	2012 Year 02 Month 06 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=R000008518