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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035625
Receipt No. 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 2019/07/25

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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
Email 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
Email y_uchida@saitama-med.ac.jp

Sponsor
Institute Saitama Medical University
Institute
Department

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
Email 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
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 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
2019 Year 07 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040581

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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