UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013628 |
|---|---|
| Receipt number | R000015908 |
| Scientific Title | Telaprevir or simeprevir-based triple therapy for recurrent hepatitis C virus among living donor liver transplant recipients |
| Date of disclosure of the study information | 2014/04/04 |
| Last modified on | 2015/10/04 15:14:21 |
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Basic information
Public title
Telaprevir or simeprevir-based triple therapy for recurrent hepatitis C virus among living donor liver transplant recipients
Acronym
TVR or SMV-based triple therapy for recurrent HCV among LDLT recipients
Scientific Title
Telaprevir or simeprevir-based triple therapy for recurrent hepatitis C virus among living donor liver transplant recipients
Scientific Title:Acronym
TVR or SMV-based triple therapy for recurrent HCV among LDLT recipients
Region
| Japan |
Condition
Condition
Chronic hepatitis C after living donor liver transplantation
Classification by specialty
| Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate safety and efficacy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sustained virologic response rates
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
Telaprevir or Simeprevir
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Null responders during or after the preemptive treatment, fibrosing cholestatic hepatitis
Key exclusion criteria
other than the above
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Sugawara |
Organization
The University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division, and Artificial Organ and Transplantation Division
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
yasusuga-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichi Kaneko |
Organization
The University of Tokyo
Division name
Hepato-Biliary-Pancreatic Surgery Division, and Artificial Organ and Transplantation Division
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
jkaneko-gi@umin.ac.jp
Sponsor or person
Institute
Hepato-Biliary-Pancreatic Surgery Division, and Artificial Organ and Transplantation Division
Institute
Department
Personal name
Funding Source
Organization
None
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
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 | 04 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 04 | Month | 04 | Day |
Last modified on
| 2015 | Year | 10 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015908
| 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 |
