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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000015501
Receipt No. R000018012
Scientific Title A prospective observational study to evaluate direct acting antivirals combination therapy for chronic hepatis C.
Date of disclosure of the study information 2014/10/22
Last modified on 2018/10/26

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Basic information
Public title A prospective observational study to evaluate direct acting antivirals combination therapy for chronic hepatis C.
Acronym A prospective observational study to evaluate DAAs combination therapy for chronic hepatis C.
Scientific Title A prospective observational study to evaluate direct acting antivirals combination therapy for chronic hepatis C.
Scientific Title:Acronym A prospective observational study to evaluate DAAs combination therapy for chronic hepatis C.
Region
Japan

Condition
Condition chronic hepatitis C
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy of DAAs combination therapy for chronic hepatitis C prospectively.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The percentage of patients with a sustained virological response 24 weeks after end
of treatment (SVR24).
Key secondary outcomes (1)Level of AFP and PIVKAII
(2)Relation of HCC development
(3)The percentage of patients with a sustained virological response 12 weeks after end
of treatment (SVR12)
(4)The percentage of patients whose serum
HCV-RNA is undetectable at weeks 1, 2, 4, 8, 12, 16, 20, 24, 36, and 48
(5)The percentage of relapses
(6)The percentage of patients with viralbreakthrough.
(7)Level of FIB-4 index, other biological markers
(8)Comparison with control group.
(9)Relationship between IL28B genotype, IFNlambda4 genotype, HCV core mutation and efficacy.

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 1)Patients infected with hepatitis C virus genotype 1
2)Without HCC when participation
3)At least 20 years old when consent is given
4)The patient has been fully informed and has an adequate understanding about the study and has given voluntary written consent before participation
Key exclusion criteria 1)Women of childbearing potential during this study
2)Using interferon and ribavirin during this study
3)Using medicine on a CYP3A4 inducer or contraindicated to combination listed in an attached document
4)Evidence of hepatic decompensation (Child-Pugh classification B or C).
5)Otherwise found ineligible as a subject by the researcher
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akito Nozaki
Organization Yokohama City University Medical Center
Division name Department of Transfusion Medicine, Gastroenterological Center
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-261-5656
Email akino@yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akito Nozaki
Organization Yokohama City University Medical Center
Division name Department of Transfusion Medicine, Gastroenterological Center
Zip code
Address 3-9 Fukuura, Kanazawa-ku, Yokohama City, 236-0004, Japan
TEL 045-261-5656
Homepage URL
Email akino@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
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 横浜市立大学附属市民総合医療センター(神奈川県)
横浜市立大学附属病院(神奈川県)
神奈川県立がんセンター(神奈川県)
横浜南共済病院(神奈川県)
済生会横浜市南部病院(神奈川県)
横浜保土ヶ谷中央病院(神奈川県)
藤沢市民病院(神奈川県)
神奈川県立足柄上病院(神奈川県)
横須賀市立市民病院(神奈川県)
秦野赤十字病院(神奈川県)
藤沢湘南台病院(神奈川県)
以上Yokohama Liver Study Group(YLSG)

Other administrative information
Date of disclosure of the study information
2014 Year 10 Month 22 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2014 Year 10 Month 21 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 24 Day
Last follow-up date
2019 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information A prospective observational study

Management information
Registered date
2014 Year 10 Month 22 Day
Last modified on
2018 Year 10 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018012

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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