UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Peginterferon or conventional interferon sequential entecavir treatment for hepatitis B e antigen positive chronic hepatitis B patients: a prospective randomized controlled trial
Title of the study (Brief title)	Peginterferon or conventional interferon sequential entecavir 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	Efficacy and safety of peginterferon or conventional interferon sequential entecavir treatment for chronic hepatitis B patients
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The reduction of HBsAg (<1,000 IU/mL) at 48 weeks after initiating entecavir treatment
Key secondary outcomes	1. The following outcomes at 48 weeks after entecavir treatment (a) HBeAg seroconversion rates (b) The reduction of HBV DNA levels (<5.0 logcopies/mL) (c) ALT normal rates (d) HBeAg seroclearance (e) HBsAg seroclearance (f) HBsAg seroconversion 2. Kinetics of HBV DNA levels 3. Kinetics of HBsAg levels 4. Kinetics of HB core-related antigen levels 5. The chenge of immunological markers 6. The regression of liver fibrosis (measured by Fibroscan)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Pegiterferon induction arm
Interventions/Control_2	Conventional interferon (natural IFN-alpha) induction arm
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	# Chronic hepatitis B patients with HBeAg positivity # Twice or more ALT flares # HBV DNA levels > 4.0 log copies/mL
Key exclusion criteria	1. Prior exposure of interferon, antiviral agents, antitumoral agents, immunosupressive drugs, and radiotherapy within 6 months 2. HCV RNA positivity 3. Complicating other liver disease 4. The diagnosis of Liver cirrhosis, hepatic failure, and liver cancer 5. The history of hepatic encephalopathy, varices bleeding, and ascites 6. Complicating collagen disease 7. The history of interstitial pneumonia 8. Severe heart disease 9. The history of epilepsy 10. The history of depression 11. The history of abnormal thyroid function 12. The history of stroke 13. Severe diabetes 14. The history of malignant tumor within 5 years 15. The history of liver, kidney or bone marrow transplantation 16. Retinopathy 17. blood test abnormality as follows: (a) neutrophil < 1,500 /mm3 (b) platelets count < 90,000/ mm3 (c) Hb < 10 g/dL (d) prothrombin time > 20s or < 60% (e) ALT > 10 times ULN (f) total bilirubin > 2.0 mg/dL (g) albmin < 3.2 g/dL (h) creatinine clearance < 50 mL/min 18. Pregnancy 19. Doctors condider inadequate
Target sample size	100

Research contact person
Name of lead principal investigator	Hiromitsu Kumada
Organization	Toranomon Hospital
Division name	Hepatology
Address	1-3-1 Kajigaya Takatsu-ku Kawasaki Kanagawa
TEL	044-877-5111
Email	kumahiro@toranomon.gr.jp

Public contact
Name of contact person	Tetsuya Hosaka
Organization	Toranomon Hospital
Division name	Hepatology
Address	1-3-1 Kajigaya Takatsu-ku Kawasaki Kanagawa
TEL	044-877-5111
Homepage URL
Email	hosa-p@toranomon.gr.jp

Sponsor
Institute	Toranomon Hospital
Institute
Department

Funding Source
Organization	Toranomon Hospital
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	2013 Year 09 Month 09 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 08 Month 21 Day
Anticipated trial start date	2013 Year 09 Month 09 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	2013 Year 09 Month 06 Day
Last modified on	2017 Year 09 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013639