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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000020124
Receipt No. R000023247
Scientific Title Efficacy of preceding administration of Entecavir with PEG-IFN-alfa2a for patients with chronic hepatitis B, positive with HBe antigen in young aged populations
Date of disclosure of the study information 2015/12/08
Last modified on 2015/12/08

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Basic information
Public title Efficacy of preceding administration of Entecavir with PEG-IFN-alfa2a for patients with chronic hepatitis B, positive with HBe antigen in young aged populations
Acronym Efficacy of preceding administration of Entecavir with PEG-IFN-alfa2a for patients with chronic hepatitis B, positive with HBe antigen in young aged populations
Scientific Title Efficacy of preceding administration of Entecavir with PEG-IFN-alfa2a for patients with chronic hepatitis B, positive with HBe antigen in young aged populations
Scientific Title:Acronym Efficacy of preceding administration of Entecavir with PEG-IFN-alfa2a for patients with chronic hepatitis B, positive with HBe antigen in young aged populations
Region
Japan

Condition
Condition Chronic hepatitis B
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the safety, and efficacy of the preceding administration of Entecavir with PEG-IFN-alfa2a for young patients with chronic hepatitis B
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of HBV-DNA titer, below 4 log copies/mL after 48 weeks of preceding administration of Entecavir with PEG-IFN-alfa2a
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 Administration of Entecavir for at least 24 weeks since the beginning of treatment
At 20 weeks, HBV-DNA titer below 4log, then switch to PEG-IFN-alfa2a
At 20 weeks, HBV-DNA titer more than 4log, Entecavir would be continued
At the onset of HBV-DNA below 4log, switch to PEG-IFN-alfa2a, continued for 48 weeks
The maxim duration of Entecavir would be 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
40 years-old >
Gender Male and Female
Key inclusion criteria 1. Age below 40 years old
2. Patient with chronic hepatitis B, untreated with IFN or nuclear analogue
Non-cirrhosis
3. Genotype C, HBe Antigen positive, HBV-DNA over 7log copies, ALT over 100IU/L
Just before the trial, Neutrophil more than 1,500/ul, Platelet more than 90,000/ul, hemoglobin more than 10g/dl
4. ECOG performance status 0 or 1
5. Obtained an informed consent from all study participants
Key exclusion criteria 1. HCV antibody positive
2. Liver cirrhosis
3. Pregnancy or lactation period
4. Entecavir or interferon therapy before the study
5. Treated with shou-saikotou (Kampo medicine)
6. Past history of interstitial pneumoniae
7. Past history of autoimmune hepatitis
8. Allergy with vaccination
9. Severe mentally disordered, severe psychotic disease
10. Others
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michihiro Suzuki
Organization St. Marianna University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa 216-8511, Japan
TEL 044-977-8111
Email michstmu@marianna-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroki Ikeda
Organization St. Marianna University School of Medicine
Division name Division of Gastroenterology and Hepatology, Department of Internal Medicine
Zip code
Address 2-16-1 Sugao, Miyamae-ku, Kawasaki City, Kanagawa 216-8511, Japan
TEL 044-977-8111
Homepage URL
Email ikedahi@marianna-u.ac.jp

Sponsor
Institute Division of Gastroenterology and Hepatology, Department of Internal Medicine, St. Marianna University School of Medicine,
Institute
Department

Funding Source
Organization Division of Gastroenterology and Hepatology, Department of Internal Medicine, St. Marianna University School of Medicine,
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 12 Month 08 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 08 Day
Last modified on
2015 Year 12 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023247

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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