UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035625 |
|---|---|
| Receipt number | R000040581 |
| Scientific Title | Efficacy and safety of sofosbuvir/belpatasvir combination tablets for patients infected with pan-genotypic hepatitis C virus |
| Date of disclosure of the study information | 2019/01/23 |
| Last modified on | 2022/07/26 09:16:17 |
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Basic information
Public title
Efficacy and safety of sofosbuvir/belpatasvir combination tablets for patients infected with pan-genotypic hepatitis C virus
Acronym
Sofosbuvir/velpatasvir therapy for patients with HCV
Scientific Title
Efficacy and safety of sofosbuvir/belpatasvir combination tablets for patients infected with pan-genotypic hepatitis C virus
Scientific Title:Acronym
Sofosbuvir/velpatasvir therapy for patients with HCV
Region
| Japan |
Condition
Condition
Chronic liver disease infected with HCV
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of sofosbuvir/velpatasvir combination tablets for patients infected with pan-genotypic hepatitis C virus, and analyze the viral factors associated with non-SVR.
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 and 24 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
Patients infected with HCV
Key exclusion criteria
1) Patients who do not have consent to clinical research
2) Patietns accompanying HCC
2) Patients with pregnancy
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Mochida |
Organization
Saitama Medical University
Division name
Department of Gastroenterology & Hepatology
Zip code
3500495
Address
38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
TEL
049-276-1198
smochida@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Uchida |
| Middle name | |
| Last name | Yoshihito |
Organization
Saitama Medical University
Division name
Department of Gastroenterology & Hepatology
Zip code
3500495
Address
38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
TEL
049-276-1198
Homepage URL
y_uchida@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
the Institutional Review Board of Saitama Medical University Hospital
Address
38 Morohongo, Moroyama-cho, Iruma-gun, 350-0495 Saitama, Japan
Tel
049-276-1125
hirb@saitama-med.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
| 2019 | Year | 01 | Month | 23 | 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
35
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 21 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 04 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
obsevatinal cohort study.
Management information
Registered date
| 2019 | Year | 01 | Month | 22 | Day |
Last modified on
| 2022 | Year | 07 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040581
