UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Peginterferon(PEG-IFN) alfa-2a in chronic hepatitis B patients with nucleos(t)ide analogues (NA) treatment
Title of the study (Brief title)	PEG-IFN for NA-experienced CH-B
Region	Japan

Condition
Condition	Nucleoside analogue experienced patients infected with hepatitis B virus infection
Classification by specialty	Hepato-biliary-pancreatic medicine
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To examine the safety and efficacy in peginterferon alfa-2a therapy in Japanese NA-experienced patients infected with hepatitis B virus (HBV)
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	HBV DNA and ALT levels at 24 week after stopping the treatment
Key secondary outcomes

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	Patients were eligible if they met the following inclusion criteria: (i) infected with HBV alone, (ii) age =>20 years, (iii) diagnosed as chronic hepatitis B, (iv) WBC =>3000/mm3 , (v) neutrophils =>1500/mm3, (vi) platelets =>90000/mm3, (vii) hemoglobin => 12 g/dL, (viii) Doctors judged patient as appropriate person in this trial , (ix) patients experienced with NA, (x)HBV DNA levels < 3 log IU/mL, (xi) no or mild hepatic fibrosis, (xii) patient and his/her family underst and well this disease and treatment.
Key exclusion criteria	1) Pregnancy 2) Severe liver diseases 3) Cirrhosis or hepatic failure such as chronic liver diseases, e.g. autoimmune hepatitis and alcoholic hepatitis 4) Severe other diseases 5) History of pneumonitis 6) Past-history of hypersensitivity against interferon or peginterferon, etc. 7) Severe mental disorders 8) Abnormal hematological exams 9) Past-history of hypersensitivity against vaccination, etc. 10) Under treatment of TJ-9 11) Doctor judged patient as inappropriate person in this trial
Target sample size	100

Research contact person
Name of lead principal investigator	Osamu Yokosuka, M.D.
Organization	Chiba University, Graduate School of Medicine
Division name	Department of Gastroenterology and Nephrology
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan (260-8677)
TEL	043-226-2086
Email	kandat-cib@umin.ac.jp

Public contact
Name of contact person	Tatsuo Kanda, M.D.
Organization	Chiba University, Graduate School of Medicine
Division name	Department of Gastroenterology and Nephrology
Address	1-8-1 Inohana, Chuo-ku, Chiba, Japan (260-8677)
TEL	043-226-2086
Homepage URL
Email	kandat-cib@umin.ac.jp

Sponsor
Institute	Chiba University, Graduate School of Medicine
Institute
Department

Funding Source
Organization	Chiba 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	Chiba University Hospital (Chiba, JPN) 千葉大学医学部附属病院(千葉県)

Other administrative information
Date of disclosure of the study information	2012 Year 05 Month 10 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 03 Month 05 Day
Anticipated trial start date	2012 Year 03 Month 07 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2017 Year 11 Month 11 Day
Date trial data considered complete	2017 Year 11 Month 11 Day
Date analysis concluded	2017 Year 11 Month 11 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	In future, we will perform the observation study.

Management information
Registered date	2012 Year 05 Month 10 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/ctr_e/ctr_view.cgi?recptno=R000009333