UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022566 |
|---|---|
| Receipt number | R000026006 |
| Scientific Title | To calculate efficacy and safety of LDV/SOF to HCV genotype 2, Phase 3b randomised non-blinded multiceter trial. |
| Date of disclosure of the study information | 2016/06/01 |
| Last modified on | 2016/06/23 13:46:40 |
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Basic information
Public title
To calculate efficacy and safety of LDV/SOF to HCV genotype 2, Phase 3b randomised non-blinded multiceter trial.
Acronym
The efficacy and safety of LDV/SOF to HCV genotype 2.
(GS-US-337-1903)
Scientific Title
To calculate efficacy and safety of LDV/SOF to HCV genotype 2, Phase 3b randomised non-blinded multiceter trial.
Scientific Title:Acronym
The efficacy and safety of LDV/SOF to HCV genotype 2.
(GS-US-337-1903)
Region
| Japan |
Condition
Condition
HCV genotype 2
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The efficacy and safety of LDV/SOF to HCV genotype 2.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SVR with 12 week after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
LDV/SOF treatment for 12 weeks
CH or LC
Interventions/Control_2
SOF/RBV treatment for 12 weeks
CH or LC
Interventions/Control_3
LDV/SOF treatment for 12 weeks
CH or LC
Not tolerant of RBV
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
CH or LC
Key exclusion criteria
HCC
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiharu Komatsu |
Organization
Shinshu University of Medicine
Division name
Gastroenterology
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2634
komichi@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiharu Komatsu |
Organization
Shinshu University of Medicine
Division name
Gastroenterology
Zip code
Address
Asahi 3-1-1, Matsumoto, Nagano
TEL
0263-37-2634
Homepage URL
komichi@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Gilead-Sciences Inc
Organization
Division
Category of Funding Organization
Outside Japan
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
| 2016 | Year | 06 | 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
Terminated
Date of protocol fixation
| 2016 | Year | 05 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This clinical trial is a part of GS-US-337-1903.We don't continue this clinical trial information in this web pages.This clinical trial results will be reported by Gilead Sciences,Inc.
Management information
Registered date
| 2016 | Year | 06 | Month | 01 | Day |
Last modified on
| 2016 | 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=R000026006
| 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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