UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017654 |
|---|---|
| Receipt number | R000020321 |
| Scientific Title | The study for simeprevir, peg-interferon, and ribavirin treatment efficacy against the patients with chronic hepatitis C (Multicenter trial) |
| Date of disclosure of the study information | 2015/05/22 |
| Last modified on | 2015/11/30 06:39:07 |
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Basic information
Public title
The study for simeprevir, peg-interferon, and ribavirin treatment efficacy against the patients with chronic hepatitis C (Multicenter trial)
Acronym
The study for simeprevir, peg-interferon, and ribavirin treatment efficacy
Scientific Title
The study for simeprevir, peg-interferon, and ribavirin treatment efficacy against the patients with chronic hepatitis C (Multicenter trial)
Scientific Title:Acronym
The study for simeprevir, peg-interferon, and ribavirin treatment efficacy
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the treatment efficacy of simeprevir, peg-interferon, and ribavirin treatment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
sustained virological response rate
Key secondary outcomes
peg-interferon alfa-2a or alfa-2b
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
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of peg-interferon alfa-2a 180ug/week for 24 weeks
Interventions/Control_2
administration of peg-interferon alfa-2b 1.5ug/kg/week for 24 weeks
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
Patients with chronic hepatitis C
Key exclusion criteria
Patients who were thought to be unsuitable
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Ebinuma |
Organization
Keio University, School of Medicine
Division name
Division of Gastroenterology & Hepatology
Zip code
Address
35 Shinanomachi Shinjuku-ku
TEL
03-3353-1211-62384
ebinuma@a5.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirotoshi Ebinuma |
Organization
Keio University, School of Medicine
Division name
Division of Gastroenterology & Hepatology
Zip code
Address
35 Shinanomachi Shinjuku-ku
TEL
03-3353-1211-62384
Homepage URL
ebinuma@a5.keio.jp
Sponsor or person
Institute
Shinanomachi Liver Conference
Institute
Department
Personal name
Funding Source
Organization
Shinanomachi Liver Conference
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
EIJU General Hospital
Kitasato Institute Hospital
Saitama Social Insurance Hospital
Saiseikai Central Hospital
National Hospital Organization Tokyo Medical Center
Saiseikai Utsunomiya Hospital
Japanese Red Cross Mito Hospital
Yokohama Municipal Citizen's Hospital
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
慶應義塾大学病院（東京都）ほか
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 12 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 05 | Month | 22 | Day |
Last modified on
| 2015 | Year | 11 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020321
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
