UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019468 |
|---|---|
| Receipt number | R000022514 |
| Scientific Title | Evaluation of the efficacy of sofosbuvir and ledipasvir for Japanese hepatitis C patients: a prospective study in real-life settings. |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2015/12/16 22:24:20 |
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Basic information
Public title
Evaluation of the efficacy of sofosbuvir and ledipasvir for Japanese hepatitis C patients: a prospective study in real-life settings.
Acronym
The efficacy of sofosbuvir and ledipasvir for Japanese hepatitis C patients
Scientific Title
Evaluation of the efficacy of sofosbuvir and ledipasvir for Japanese hepatitis C patients: a prospective study in real-life settings.
Scientific Title:Acronym
The efficacy of sofosbuvir and ledipasvir for Japanese hepatitis C patients
Region
| Japan |
Condition
Condition
chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Identifying the predictive factors of virological response in sofosbuvir and ledipasvir treatment
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
sustained virological response (SVR) at 12 week and 24 week after the end of treatment
Key secondary outcomes
incidence rate of adverse events
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
sofosbuvir and ledipasvir combination tablets
a fixed-dose combination tablet containing 90mg of ledipasvir and 400mg of sofobuvir orally, once daily for 12 weeks
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 and compensated cirrhotic patients with HCV genotype 1
naive and DAA treatment experienced patients
Key exclusion criteria
decompensated cirrhosis
coexisting heart disease
renal impairment
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Fumitaka Suzuki |
Organization
Toranomon Hospital
Division name
hepatology
Zip code
Address
2-2-2, Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
hitomis@mx1.harmonix.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitomi Sezaki |
Organization
Toranomon Hospital
Division name
hepatology
Zip code
Address
2-2-2, Toranomon, Minato-ku, Tokyo
TEL
03-3588-1111
Homepage URL
hitomis@mx1.harmonix.ne.jp
Sponsor or person
Institute
Toranomon Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
虎の門病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 11 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | 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
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2015 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022514
