UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013597 |
|---|---|
| Receipt number | R000015886 |
| Scientific Title | The randomized trial of Peginterferon alfa 2a or alfa2b with simeprevir and ribavirin for chronic hepatitis C |
| Date of disclosure of the study information | 2014/04/10 |
| Last modified on | 2014/04/01 22:08:13 |
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Basic information
Public title
The randomized trial of Peginterferon alfa 2a or alfa2b with simeprevir and ribavirin for chronic hepatitis C
Acronym
The randomized trial of Peginterferon alfa 2a or alfa2b with simeprevir and ribavirin for chronic hepatitis C
Scientific Title
The randomized trial of Peginterferon alfa 2a or alfa2b with simeprevir and ribavirin for chronic hepatitis C
Scientific Title:Acronym
The randomized trial of Peginterferon alfa 2a or alfa2b with simeprevir and ribavirin for chronic hepatitis C
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the efficacy and safety of simeprevir with peginterferon and ribavirin and to explore the independent factors of SVR
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of sustained virological response 24 weeks after the end of treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Uncontrolled
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
Patients receive simeprevir and peginterferon alfa 2b/ribavirin for 12 weeks followed by peginterferon alfa 2b/ribavirin for 12 weeks
Interventions/Control_2
Patients receive simeprevir and peginterferon alfa 2a/ribavirin for 12 weeks followed by peginterferon alfa 2a/ribavirin for 12 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
1.over than 20 years old
2.Positive of HCV-RNA and comfirmed the serogroup 1 HCV infection
3.Neutrophil count >1,500/microl, Platelet count > 80,000/microl and Hb > 10 g/dl
4.Absence of HCC
5.agreement of this trial and obtain informed consent
6.Not received PSE or splenectomy
Key exclusion criteria
1.pregnancy or breast feeding female
severe allergy to IFN
2, 3.severe allergy to RBV or nucreosid analogue
4.uncontrolled cardiac diseases
5.Hemoglobinopathies
6.chronic renal failure or less than 50 ml /min of CCr
7.severe psychiatric disorder
8.severe cirrhotic patients
9.The history of interstitial pneumonitis
10.Autoimmune hepatitis
11.The history of the allergy to biochemical agents
12.receiving disallowed drugs
13.uncontrolled diabetes mellitus
14.patients with HCC(except for curative patients)
15.co-infection of HBV and/or HIV
16.patients who not permit the participate this study
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | yutaka sasaki |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 honjyo chuo-ku, kumamoto city
TEL
096-373-5150
gastro@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masakuni tateyama |
Organization
Graduate School of Medical Sciences, Kumamoto University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
1-1-1 honjyo chuo-ku, kumamoto city
TEL
096-373-5150
Homepage URL
mtate-kmj@umin.ac.jp
Sponsor or person
Institute
Graduate School of Medical Sciences, Kumamoto University, Department of Gastroenterology and Hepatology
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 | 04 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 11 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 01 | Month | 10 | 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
| 2014 | Year | 04 | Month | 01 | Day |
Last modified on
| 2014 | Year | 04 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015886
| 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 |
