UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050343 |
|---|---|
| Receipt number | R000057320 |
| Scientific Title | Efficacy and Safety of sofosbuvir/velpatasvir for HCV infected patients with decompensated LC |
| Date of disclosure of the study information | 2023/02/14 |
| Last modified on | 2023/02/14 23:59:32 |
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Basic information
Public title
Efficacy and Safety of sofosbuvir/velpatasvir for HCV infected patients with decompensated LC
Acronym
Efficacy and Safety of sofosbuvir/velpatasvir
Scientific Title
Efficacy and Safety of sofosbuvir/velpatasvir for HCV infected patients with decompensated LC
Scientific Title:Acronym
Efficacy and Safety of sofosbuvir/velpatasvir
Region
| Japan |
Condition
Condition
HCV infected patients with decompensated LC
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the Real-World effectiveness of SOF/VEL in HCV-related decompensated cirrhosis patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of sustained virological response at 12 weeks after SOF/VEL completion
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) Patients with HCV related decompensated LC 2) Patients aged 20 years or older at the time of consent 3) Patients who received an adequate explanation prior to the study and provided written consent for participation in the study
Key exclusion criteria
1 patients judged to be inappropriate to participate in the study by the attending physician
2 patients judged to be inappropriate to participate in the study by the primary physician
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | GOKI |
| Middle name | |
| Last name | SUDA |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
0608638
Address
North 15, West 7, Kita-ku, Sapporo,
TEL
0117161161
gsudgast@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | GOKI |
| Middle name | |
| Last name | SUDA |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
0608638
Address
North 15, West 7, Kita-ku, Sapporo,
TEL
0117161161
Homepage URL
gsudgast@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
gilead sciences inc
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
North 14, West 5, Kita-ku, Sapporo,
Tel
011-706-7636
crjimu@huhp.hokudai.ac. jp
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
| 2023 | Year | 02 | Month | 14 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 12 | Month | 12 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 12 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Labo datas
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057320
| 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 |
