UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015501 |
|---|---|
| Receipt number | 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 08:38:03 |
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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
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
akino@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Institute
Department
Personal name
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
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
Value
https://center6.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 |
