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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017654
Receipt No. 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

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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
Email 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
Email ebinuma@a5.keio.jp

Sponsor
Institute Shinanomachi Liver Conference
Institute
Department

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
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 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
URL(English) https://upload.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
Registered date File name


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