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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035711
Receipt No. R000040680
Scientific Title Evaluation of the efficacy of sofosbuvir and velpatasvir in HCV-infected Japanese patients with decompensated cirrhosis: a prospective study in real life settings.
Date of disclosure of the study information 2019/03/01
Last modified on 2019/01/29

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Basic information
Public title Evaluation of the efficacy of sofosbuvir and velpatasvir in HCV-infected Japanese patients with decompensated cirrhosis: a prospective study in real life settings.
Acronym The efficacy of sofosbuvir and velpatasvir in HCV-infected Japanese patients with decompensated cirrhosis.
Scientific Title Evaluation of the efficacy of sofosbuvir and velpatasvir in HCV-infected Japanese patients with decompensated cirrhosis: a prospective study in real life settings.
Scientific Title:Acronym The efficacy of sofosbuvir and velpatasvir in HCV-infected Japanese patients with decompensated cirrhosis.
Region
Japan

Condition
Condition decompensated cirrhotic patients with hepatitis C virus
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Identifying the predictive factors of virological response in sofosbuvir and velpatasvir treatment.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes sustained virological response (SVR) at 12 weeks after the end of treatment (EOT)
Key secondary outcomes SVR at 24 weeks after the EOT
incidence rate of adverse events durig treatment
the change of Child-Pugh score at 12 and 24 weeks after the EOT from baseline

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 decompensated cirrhotic patients with HCV RNA
Key exclusion criteria Child-Pugh A
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumitaka Suzuki
Organization Toranomon Hospital
Division name hepatology
Zip code
Address 2-2-2, Toranomon, Minato-ku, Tokyo
TEL 03-3588-1111
Email fumitakas@toranomon.gr.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hitomi Sezaki
Organization Toranomon Hospital
Division name hepatology
Zip code
Address 2-2-2, Toranomon, Minato-ku, Tokyo
TEL 03-3588-1111
Homepage URL
Email hitomis@mx1.harmonix.ne.jp

Sponsor
Institute Toranomon Hospital
Institute
Department

Funding Source
Organization Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization Japan

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 虎の門病院(東京)

Other administrative information
Date of disclosure of the study information
2019 Year 03 Month 01 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 28 Day
Date of IRB
Anticipated trial start date
2019 Year 03 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 combination tablet of sofosbuvir/velpatasvir(400mg/100mg) one tablet once daily for 12 weeks.
Evaluating the association with baseline characteristics (viral factors and host factors) and virological response.

Management information
Registered date
2019 Year 01 Month 29 Day
Last modified on
2019 Year 01 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040680

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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