UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Analysis for the efficacy and safety of peginterferon-alpha-2a monotherapy on chronic active hepatitis B patients
Title of the study (Brief title)	Peginterferon-alpha-2a monotherapy in patients with chronic hepatitis B
Region	Japan

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

Objectives
Narrative objectives1	To examine the efficacy and safety of peginterferon-alpha-2a monotherapy in patients with chronic active hepatitis B.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	<Efficacy> A. In patients with HBe Ag positive chronic hepatitis B at the start of therapy. At the 24 weeks after the end of therapy 1. The proportion of patients with HBe Ag seroconvertsion. 2. The proportion of patients achieving HBV DNA less than 5.0 log copies/mL. 3. The proportion of patients achieving ALT 40 U/L and fewer. B. In patients with HBe Ag negative chronic hepatitis B at the start of therapy. At the 24 weeks after the end of therapy 1. The proportion of patients achieving HBV DNA less than 4.3 log copies/mL 2. The proportion of patients achieving ALT 40 U/L and fewer. <Safety> 1. Adverse events, clinical laboratory tests (the changes in neutrophil and , platelet counts, hemoglobin levels) 2. Treatment continuation, reduction, and discountinuation rates, the reason for discontinuation of treatment.
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-interferon alpha-2a (Pegasys) 180 microg/week subcutaneously for 48 weeks
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	1. Patients aged 20 years old and over. 2. Patients with chronic hepatitis B. 3. Patients who meet the following conditions before the start of therapy. A. Neutrophil counts; 1,500 microliter and over. B. Platelet counts; 90,000 microliter and over. C. Hemoglobin concentrations; 10 g/dL and over. 4. Patients who is explained well about this study and is obtained signed informed consent form to this study with free will.
Key exclusion criteria	Patients with the following are excluded: 1. Patients who are taking herbal medicine, syo-saiko-to. 2. Previous history of interstitial pneumonia. 3. Other chronic liver diseases such as autoimmune hepatitis, alcoholic liver disease. 4. Previous history of hypersensitivity to peginterferon-alpha-2a or other interferon products. 5. Previous history of hypersensitivity to biologicals such as vaccines. 6. Liver cirrhosis, liver failure and hepatocellular carcinoma. 7. Patients who have hepatic encephalaopathy, esophageal varices, ascites, or those previous history. 8. Patients who have autoimmune diseases such as hemolytic anemia, ulcerative colitis, rheumatoid arthritis, or those previous history. 9. Patients who have heart diseases difficult to control. 10. Patients who have depression, epileptic seizure, or mental disorders with continuous treatment, or those previous history. 11. Uncontrollable hypertension. 12. Previous history of cerebrovascular diseases such as brain infarction, cerebral hemorrhage, subarachnoid hemorrhage or transient ischemic attack. 13. Diabetes mellitus receiving medical treatment. 14. Patients who are pregnant or lactating women. 15. Patients who are receiving nucleotide analogues treatments within three months. 16. Patients who are disquialified to participate in this trial judged by attending physician.
Target sample size	50

Research contact person
Name of lead principal investigator	Norihiro Furusyo
Organization	Kyushu University Hospital
Division name	Department of general internal medicine
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5909
Email	furusyo@gim.med.kyushu-u.ac.jp

Public contact
Name of contact person	Masayuki Murata
Organization	Kyushu University Hospital
Division name	Department of general internal medicine
Address	3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL	092-642-5909
Homepage URL
Email	mmurata@gim.med.kyushu-u.ac.jp

Sponsor
Institute	Department of general internal medicine, Kyushu-University hospital
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	2015 Year 06 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 07 Month 24 Day
Anticipated trial start date	2013 Year 07 Month 24 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	2015 Year 06 Month 22 Day
Last modified on	2017 Year 12 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000020671