UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013749 |
|---|---|
| Receipt number | R000016044 |
| Scientific Title | Therapeutic effect of Peg-IFN therapy combined with RBV and simeprevir(SMV) on patients with chronic hepatitis C - a multicenter study - |
| Date of disclosure of the study information | 2014/04/18 |
| Last modified on | 2014/04/17 16:57:59 |
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Basic information
Public title
Therapeutic effect of Peg-IFN therapy combined with RBV and simeprevir(SMV) on patients with chronic hepatitis C
- a multicenter study -
Acronym
Therapeutic effect of SMV on patients with chronic hepatitis C
Scientific Title
Therapeutic effect of Peg-IFN therapy combined with RBV and simeprevir(SMV) on patients with chronic hepatitis C
- a multicenter study -
Scientific Title:Acronym
Therapeutic effect of SMV on patients with chronic hepatitis C
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and efficacy of simeprevir on patients with chronic hepatitis C
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sustained virologic response rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Peg-IFN-alpha2b/RBV/SMV 12 weeks plus Peg-IFN-alpha2b/RBV 12 weeks: a total of 24 weeks treatment
Interventions/Control_2
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
Chronic hepatitis C patients with HCV serotype 1
laboratory data before study treatment
neutrophil count over 1,500/mm3
platelet count over 100,000/mm3
hemoglobin over 12g/dl
Key exclusion criteria
Patients who did not fulfill the criteria to receive the approved Peg-IFN-alpha2b/RBV/SMV treatment
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akio Ido |
Organization
Kagoshima university
Division name
Division of digestive and lifestyle disease
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
099-275-5326
ido-akio@m2.kufm.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiro Moriuchi |
Organization
Kagoshima university
Division name
Division of digestive and lifestyle disease
Zip code
Address
8-35-1 Sakuragaoka, Kagoshima 890-8520, Japan
TEL
099-275-5326
Homepage URL
akimori@m2.kufm.kagoshima-u.ac.jp
Sponsor or person
Institute
Division of digestive and lifestyle disease, Kagoshima university graduate school of medical and dental sciences
Institute
Department
Personal name
Funding Source
Organization
Division of digestive and lifestyle disease, Kagoshima university graduate school of medical and dental sciences
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyushu hepatitis C study group
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 | 18 | 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 | 30 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 12 | Month | 01 | 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 | 17 | Day |
Last modified on
| 2014 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016044
