UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015933 |
|---|---|
| Receipt number | R000018546 |
| Scientific Title | Inhibition Effects of Hepatocellular Carcinoma Developments for Interferon-Free, Direct-Acting Antiviral Agents for Hepatitis C Virus |
| Date of disclosure of the study information | 2014/12/13 |
| Last modified on | 2022/12/19 14:54:24 |
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Basic information
Public title
Inhibition Effects of Hepatocellular Carcinoma Developments for Interferon-Free, Direct-Acting Antiviral Agents for Hepatitis C Virus
Acronym
DAAs for HCV and Hepatocellular Carcinoma Developments
Scientific Title
Inhibition Effects of Hepatocellular Carcinoma Developments for Interferon-Free, Direct-Acting Antiviral Agents for Hepatitis C Virus
Scientific Title:Acronym
DAAs for HCV and Hepatocellular Carcinoma Developments
Region
| Japan |
Condition
Condition
the patients with infected Hepatitis C virus(HCV)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether HCC were reduced by Interferon-Free, DAAs as IFN
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The periods and numbers of HCC developments
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
The DAAs group who achieved sustained viral response (SVR) by DAAs, such as sofosbuvir, ledipasvir and ribavirin.
The IFN group who achieved sustained viral response (SVR) by PegIFN/RBV/Protease inhibitor, such as
Telaprevir(TVR) Simeprevir (SMV) or Vaniprevir (VAN)
Key exclusion criteria
non SVR
IFN without Protease inhibitor
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Mizokami |
Organization
National Center for Global Health and Medicine (NCGM)
Division name
The Research Center for Hepatitis and Immunology
Zip code
2728516
Address
1-7-1 Kohnodai, Ichikawa Chiba 272-8516 Japan
TEL
047-372-3501
mizokami0810@gmail.com
Public contact
Name of contact person
| 1st name | Masaaki |
| Middle name | |
| Last name | Korenaga |
Organization
National Center for Global Health and Medicine (NCGM)
Division name
The Research Center for Hepatitis and Immunology
Zip code
2728516
Address
1-7-1 Kohnodai, Ichikawa Chiba 272-8516 Japan
TEL
047-372-3501
Homepage URL
dmkorenaga@hospk.ncgm.go.jp
Sponsor or person
Institute
The Research Center for Hepatitis and Immunology
National Center for Global Health and Medicine (NCGM)
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine (NCGM)
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
National Center for Global Health and Medicine (NCGM)
Address
1-21-1 toyama sinjyuku toukyo
Tel
0332027181
rinrijm@hosp.ncgm.go.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
| 2014 | Year | 12 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
609
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
Main results already published
Date of protocol fixation
| 2014 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2014 | Year | 11 | Month | 28 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 12 | Month | 31 | Day |
Other
Other related information
We confirm whether SOFLDV can reduces HCC incidence after eradiation of HCV as IFN.
The observation periods in this study are 5 years.
Management information
Registered date
| 2014 | Year | 12 | Month | 13 | Day |
Last modified on
| 2022 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018546
| Research Plan | |
|---|---|
| Registered date | File name |
| 2016/12/14 | 2.計画書IFN free第120版20160808.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2016/12/14 | 症例報告書.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2016/12/14 | 発癌研究まとめFDC20160812.xlsx |
