UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016275 |
|---|---|
| Receipt number | R000018814 |
| Scientific Title | The effectiveness of peginterferon -alpha2a and the entecavir combination therapy for the chronic hepatitis B patient |
| Date of disclosure of the study information | 2015/01/20 |
| Last modified on | 2021/07/30 12:58:44 |
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Basic information
Public title
The effectiveness of peginterferon -alpha2a and the entecavir combination therapy for the chronic hepatitis B patient
Acronym
The effectiveness of peginterferon and the entecavir combination therapy
Scientific Title
The effectiveness of peginterferon -alpha2a and the entecavir combination therapy for the chronic hepatitis B patient
Scientific Title:Acronym
The effectiveness of peginterferon and the entecavir combination therapy
Region
| Japan |
Condition
Condition
Chronic Hepatitis B
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to eavaluate the effectiveness of peginterferon -alpha2a and the entecavir combination therapy for the chronic hepatitis B patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To measure the primary and secondary endpoint regarding cases performed the entecavir and peginterferon -alpha2a combination therapy
Key secondary outcomes
Base
Study type
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
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
PEG-Interferon-alpha2a + Entecavir
Interventions/Control_2
Entecavir
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
*Genotype C, chronic hepatitis B patients
*Written informed consent
Key exclusion criteria
*Under 20 years-old
*Patients with the past of other IFN and nucleotide analog preparation dosage within the past one year
*Patients with a history of the past of hypersensitivity for PEG-IFN-alpha2a or other IFN preparation
*Patients with a history of the past of hypersensitivity for biological preparation such as vaccine
*Patients with a history of the past of hypersensitivity for an ingredient of Entecavir
*Pregnant or lactating patients
*Other hepatitis patients like HCV/HDV/HIV
*Other chronic liver diseases (autoimmune hepatitis, alcoholic hepatitis, and so on)
*Failure of other organs and immunodeficiency patients
*Patients with a history or in the presence of severe psychotic depression or other severe psychotic diseases patients
*Inappropriate for this study patients
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoshi Nishida |
Organization
Kinki University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
naoshi@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoru Hagiwara |
Organization
Kinki University School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka
TEL
072-366-0221
Homepage URL
hagi-318@hotmail.co.jp
Sponsor or person
Institute
Kinki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
not applicable
Organization
Division
Category of Funding Organization
Other
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 | 01 | Month | 20 | 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
Completed
Date of protocol fixation
| 2014 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2014 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 01 | Month | 20 | Day |
Last modified on
| 2021 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018814
| Research Plan | |
|---|---|
| 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 |
