UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017988 |
|---|---|
| Receipt number | R000020839 |
| Scientific Title | Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C |
| Date of disclosure of the study information | 2015/06/20 |
| Last modified on | 2019/06/23 09:14:12 |
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Basic information
Public title
Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C
Acronym
Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C
Scientific Title
Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C
Scientific Title:Acronym
Efficacy and safety of peg-IFN+RBV combined therapy in failure of direct antiviral agents therapy for chronic hepatitis C and liver cirrhosis C
Region
| Japan |
Condition
Condition
Chronic hepatitis and compensated liver cirrhosis, type C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of efficacy and safety for pegIFN plus RBV combined therapy against chronic hepatitis and compensated liver cirrhosis type C
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sustained virological response
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PegIFN plus RBV
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
good informed patients
Key exclusion criteria
un-tolerable for combined therapy
de compensated liver cirrhosis
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shinji Shimoda |
| Middle name | |
| Last name | Shinji Shimoda |
Organization
Faculty of Medicine, Kyushu University
Division name
Dept. of Medicine and Biosystemic Science
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5231
sshimoda@intmed1.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinji Shimoda |
| Middle name | |
| Last name | Shinji Shimoda |
Organization
Faculty of Medicine, Kyushu University
Division name
Dept. of Medicine and Biosystemic Science
Zip code
8128582
Address
3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5231
Homepage URL
sshimoda@intmed1.med.kyushu-u.ac.jp
Sponsor or person
Institute
Faculty of Medicine, Kyushu University
Dept. of Medicine and Biosyste
Institute
Department
Personal name
Funding Source
Organization
Faculty of Medicine, Kyushu University
Dept. of Medicine and Biosyste
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyushu University Hospital
Address
Fukuoka City, Higashi-Ku
Tel
092-642-5228
sshimoda@intmed1.med.kyushu-u.ac.jp
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
| 2015 | Year | 06 | Month | 20 | 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
0
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
| 2015 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2019 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 20 | Day |
Last modified on
| 2019 | Year | 06 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020839
