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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035511
Receipt No. 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 2019/01/10

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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
Middle name
Last name Kanji Yamaguchi
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
Address 465, Kajii-chou, Kawaramachi, Kamigyou-ku,Kyoto 602-0841, Japan
TEL 075-251-5519
Email ykanji@koto.kpu-m.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Fujii
Organization Kyoto Prefectural University of Medicine
Division name Department of Molecular Gastroenterology and Hepatology
Zip code
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/
Email fuhideki@koto.kpu-m.ac.jp

Sponsor
Institute Kyoto Prefectural University of Medicine, Department of Molecular Gastroenterology and Hepatology
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2019 Year 01 Month 10 Day
Date of IRB
Anticipated trial start date
2019 Year 02 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 Observation study

Management information
Registered date
2019 Year 01 Month 10 Day
Last modified on
2019 Year 01 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040449

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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