UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050842 |
|---|---|
| Receipt number | R000057940 |
| Scientific Title | sofosbuvir/velpatasvir for Japanease patients with hepatitis C |
| Date of disclosure of the study information | 2023/04/14 |
| Last modified on | 2023/04/14 09:13:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Efficacy and safety of Sofosbuvir and Velpatasvir for Japanese patients with HCV related hepatitis in real-world setting
Acronym
sofosbuvir/velpatasvir for Japanease patients with hepatitis C
Scientific Title
sofosbuvir/velpatasvir for Japanease patients with hepatitis C
Scientific Title:Acronym
SOF/VEL for hepatitis C in Japan
Region
| Japan |
Condition
Condition
chronic hepatitis C patients with or without compensated cirrhosis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the combination of sofosbuvir and velpatasivir in chronic hepatitis C patients with or without compensated cirrhosis and to determine predictors of treatment effect by hepatitis C virus (HCV) and host factor analysis. In addition, the frequency of outpatient visits, safety, and efficacy will also be examined.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
HCV-RNA conversion rate at 12 weeks after the end of treatment, occurrence of adverse reactions
Key secondary outcomes
1) Assessment of the number of visits during treatment, therapeutic effects, and safety
2) Emergence of drug resistance mutations in non-responders
3) Improvement in liver fibrosis and Child-pugh score
4) AFP improvement effect
5) Glucose-Lipid-Related Factors and Therapeutic Effects
6) Effect of virus elimination on renal disorder Adverse events
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
Subjects
Subjects will be chronic hepatitis C patients with or without compensated cirrhosis who visit or are admitted to the study sites participating in this study between the day of permission to conduct the study and June 2025.
Inclusion Criteria
1. The subject is aged 20 years or older at the time of informed consent.
2. Patients with chronic hepatitis C with or without compensated cirrhosis treated with the combination of sofosbuvir and velpatasivir for 12 weeks in routine clinical practice
3. A person who has received sufficient explanation before participation in this research and obtained voluntary consent of the subject himself/herself with sufficient understanding
Key exclusion criteria
Exclusion Criteria
1.Patients who are judged by the research lead to be inappropriate for participation in this review
2.Other persons who are judged by the principal investigator to be inappropriate as research subjects
*Patients who discontinue treatment due to adverse drug reactions, etc. will not be excluded from the study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | GOKI |
| Middle name | |
| Last name | SUDA |
Organization
Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
0608638
Address
North 15, West 7, Kita-ku, Sapporo,
TEL
011-716-1161
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
+819012640151
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 | 04 | 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
| 2023 | Year | 01 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
blood tests
Management information
Registered date
| 2023 | Year | 04 | Month | 14 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057940
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
