UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024007 |
|---|---|
| Receipt number | R000027640 |
| Scientific Title | Effectiveness and safety of ledipasvir and sofosbuvir for patients infected with HCV genotype 1 in clinical practices |
| Date of disclosure of the study information | 2016/09/12 |
| Last modified on | 2017/09/16 05:35:09 |
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Basic information
Public title
Effectiveness and safety of ledipasvir and sofosbuvir for patients infected with HCV genotype 1 in clinical practices
Acronym
Ledipasvir and sofosbuvir treatment for HCV genotype 1 patients
Scientific Title
Effectiveness and safety of ledipasvir and sofosbuvir for patients infected with HCV genotype 1 in clinical practices
Scientific Title:Acronym
Ledipasvir and sofosbuvir treatment for HCV genotype 1 patients
Region
| Japan |
Condition
Condition
Chronic hepatitis C genotype 1
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To assess the effectiveness and safety of ledipasvir/sofosbuvir treatment in multicenter, real-world cohort study
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rates of Sustained virological response at 12 weeks after the end of treatment
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
Chronic HCV genotype 1 infection
Key exclusion criteria
(1)Decompensated cirrhosis (Child B/C)
(2)Autoimmune hepatitis or primary biliary cholangiris
(3)eGFR<30
(4)Positivity for antibody to HIV
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Furusyo |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
furusyo@gim.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eiichi Ogawa |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
092-642-5909
Homepage URL
eogawa@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University
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
| 2016 | Year | 09 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 09 | Month | 01 | 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
Multicenter, obsevatinal cohort study
Management information
Registered date
| 2016 | Year | 09 | Month | 12 | Day |
Last modified on
| 2017 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027640
