UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016558 |
|---|---|
| Receipt number | R000017954 |
| Scientific Title | Analysis of efficacy and safety of antiviral therapy with daclatasvir and asunaprevir for hepatitis C after organ transplantation -Pilot Study- |
| Date of disclosure of the study information | 2015/02/16 |
| Last modified on | 2018/06/12 21:17:43 |
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Basic information
Public title
Analysis of efficacy and safety of antiviral therapy with daclatasvir and asunaprevir for hepatitis C after organ transplantation -Pilot Study-
Acronym
Interferon-free therapy for posttransplant hepatitis C
Scientific Title
Analysis of efficacy and safety of antiviral therapy with daclatasvir and asunaprevir for hepatitis C after organ transplantation -Pilot Study-
Scientific Title:Acronym
Interferon-free therapy for posttransplant hepatitis C
Region
| Japan |
Condition
Condition
hepatitis C after transplantation
Classification by specialty
| Hepato-biliary-pancreatic medicine | Surgery in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the pharmacokinetics, efficacy and safety of antiviral therapy with dacltasvir and asunaprevir for hepatitis C after organ transplantation
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics of antiviral therapy with dacltasvir and asunaprevir for hepatitis C after organ transplantation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1. Hepatitis C after organ transplantation
2. HCV genotype 1
3. 20 years old and over
4. Written informed consent for participation in this study is obtained
Key exclusion criteria
without abilty to understand informed consent
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Ohdan |
Organization
Hiroshima University Hospital
Division name
Trasnplantation surgery
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5220
hohdan@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Ide |
Organization
Hiroshima University Hospital
Division name
Trasnplantation surgery
Zip code
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-5222
Homepage URL
ideken@hiroshima-u.ac.jp
Sponsor or person
Institute
Trasnplantation surgery, Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Trasnplantation surgery, Hiroshima University Hospital
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
| 2015 | Year | 02 | Month | 16 | 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
| 2014 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 11 | 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
We will observe the pharmacokinetics, efficacy and safety of anti-viral therapy with daclatasvir and asunaprevir for hepatitis C after organ transplantatio, and analyze teh predictive factors of the efficacy and safety.
Management information
Registered date
| 2015 | Year | 02 | Month | 16 | Day |
Last modified on
| 2018 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017954
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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