UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013302 |
|---|---|
| Receipt number | R000015514 |
| Scientific Title | Comparison of effects and safety between peginterferon alfa-2a and peginterferon alfa-2b in simepurevir therapy for chronic hepatitis C. |
| Date of disclosure of the study information | 2014/03/03 |
| Last modified on | 2018/09/02 11:03:52 |
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Basic information
Public title
Comparison of effects and safety between peginterferon alfa-2a and peginterferon alfa-2b in simepurevir therapy for chronic hepatitis C.
Acronym
Comparison of peginterferon alfa-2a versus peginterferon alfa-2b in simepurevir therapy.
Scientific Title
Comparison of effects and safety between peginterferon alfa-2a and peginterferon alfa-2b in simepurevir therapy for chronic hepatitis C.
Scientific Title:Acronym
Comparison of peginterferon alfa-2a versus peginterferon alfa-2b in simepurevir therapy.
Region
| Japan |
Condition
Condition
Chronic hepatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
efficacy and safety
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
SVR ratio
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
alfa 2a
Interventions/Control_2
alfa 2b
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
| 75 | years-old | > |
Gender
Male and Female
Key inclusion criteria
over 20 years old and under 75 years old
Key exclusion criteria
there is no problem about randomaization
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Koichi Honda |
Organization
Oita University
Division name
Department of gastroenterology
Zip code
Address
Yufu-shi, Hasama-machi
TEL
097-54904411
hondak@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koichi Honda |
Organization
Oita Hepatitis C Study
Division name
Gastroenterology
Zip code
Address
Yufu-shi, Hasama-machi
TEL
097-549-4411
Homepage URL
hondak@oita-u.ac.jp
Sponsor or person
Institute
Oita hepatitis C study
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2014 | Year | 03 | Month | 03 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 02 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 03 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2018 | Year | 10 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 02 | Month | 28 | Day |
Last modified on
| 2018 | Year | 09 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015514
