UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000035511 |
|---|---|
| Receipt number | R000040449 |
| Scientific Title | Study of real world efficacy and drug resistance associated substitutions of Sofosbuvir and Velpatasvir treatment for patients with HCV infection |
| Date of disclosure of the study information | 2019/01/15 |
| Last modified on | 2020/01/13 23:45:22 |
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Basic information
Public title
Study of real world efficacy and drug resistance associated substitutions of Sofosbuvir and Velpatasvir treatment for patients with HCV infection
Acronym
Study of real world efficacy and drug resistance associated substitutions of Sofosbuvir and Velpatasvir treatment
Scientific Title
Study of real world efficacy and drug resistance associated substitutions of Sofosbuvir and Velpatasvir treatment for patients with HCV infection
Scientific Title:Acronym
Study of real world efficacy and drug resistance associated substitutions of Sofosbuvir and Velpatasvir treatment
Region
| Japan |
Condition
Condition
Hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recently, direct-acting antiviral agents (DAAs) which specifically effect for HCV virus is developed. The first generation treatment of Daclatasvir/Asunaprevir were available to HCV infected patients with chronic hepatitis or compensated cirrhosis from 2014 in Japan. After that, several regimens were approved, like Sofosbuvir (SOF)/ Ledipasvir, Ombitasvir/Paritaprevir/ritonavir, Elbasvir/Grazoprevir, Ombitasvir/Paritaprevir/ritonavir/Ribavirin, and Glecaprevir/Pibrentasvir. Progress in these treatment lead to eradicate HCV for many patients. Though sustained virological response(SVR) rates were over 95%, a small number of patients could not achieved SVR.
Drug resistance virus due to resistance-associated substitutions (RASs) closely involved the efficacy of DAAs. (Pawlotsky JM et al. Gastroenterology. 151; 70-86: 2016). These resistance virus was induced in patients who could not achieved SVR. They resistant to the re-treatment of DAAs. Moreover, decompensated cirrhosis patients were not approved by DAAs treatments.
SOF/Velpatasvir regimen is approved for patients of re-treatment or decompensated cirrhosis patients. SVR 12 rates were 97% for DAA failure and 92% for decompensated cirrhosis patients. (GS-US-342-3921study, GS-US-342-4019study)
But it has not been reported on the real world efficacy and association between RASs and efficacy. We plane multicenter study.
1. Real world efficacy of SOF/Velpatasvir regimen
2. Association between RASs and efficacy.
It is important to clarify these clinical question for DAAs treated patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sustained virological response rates :after 12 weeks of end of treatment
Key secondary outcomes
Liver function change between before and after treatment. Liver cirrhosis associated events.Presence of resistance-associated substitutions
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
Eligible patients were 20 years age <= HCV infected patients.
Key exclusion criteria
Patients with coinfection with hepatitis B virus or human immunodeficiency virus, autoimmune hepatitis, primary biliary cirrhosis, hemochromatosis or Wilson's disease were excluded. Patients with uncontrollable hypertension or diabetes mellitus and those with a history of alcohol abuse were also excluded.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kanji |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
6028566
Address
465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
TEL
075-251-5519
ykanji@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | HIDEKI |
| Middle name | |
| Last name | Fujii |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Molecular Gastroenterology and Hepatology
Zip code
6028566
Address
465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
TEL
075-251-5519
Homepage URL
http://www.f.kpu-m.ac.jp/k/syokanai/
fuhideki@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Department of Molecular Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine, Department of Molecular Gastroenterology and Hepatology
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
ethical committee
Address
465, Kajii-chou, Kamigyo-u, Kyoto,
Tel
0752515337
rinri@koto.kpu-m.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 | 15 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observation study
Management information
Registered date
| 2019 | Year | 01 | Month | 10 | Day |
Last modified on
| 2020 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000040449
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