UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020124 |
|---|---|
| Receipt number | 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 22:25:04 |
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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
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
ikedahi@marianna-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Department of Internal Medicine, St. Marianna University School of Medicine,
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023247
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
