UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017329 |
|---|---|
| Receipt number | R000020105 |
| Scientific Title | Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2016/11/01 15:46:40 |
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Basic information
Public title
Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study
Acronym
Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study
Scientific Title
Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study
Scientific Title:Acronym
Efficacy of antiviral therapy in hepatitis C patients aged 70 years or older: multicenter prospective observational study
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The non-inferiority of IFN-free therapy to IFN-based therapy on risk for hepatocellular carcinoma in patients with SVR
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rates of hepatocarcinogenesis
Key secondary outcomes
Overall survival
Rates of SVR
Rates of interruption of antiviral therapy due to adverse effect
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
| 70 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Chronic hepatitis C patients aged 70 years or older undergoing antiviral therapy (IFN-free or IFN-based) after 2004.
Key exclusion criteria
Present illness or past history of hepatocellular carcinoma
Positive Hepatitis B viral DNA
Target sample size
516
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Katsushima |
Organization
Kyoto Medical Center, National Hospital Organization
Division name
Department of Gastroenterology
Zip code
Address
1-1, Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL
81-75-641-9161
skatsush@kyotolan.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Katsushima |
Organization
Kyoto Medical Center, National Hospital Organization
Division name
Department of Gastroenterology
Zip code
Address
1-1, Mukaihata-cho, Fukakusa, Fushimi-ku, Kyoto 612-8555, JAPAN
TEL
81-75-641-9161
Homepage URL
skatsush@kyotolan.hosp.go.jp
Sponsor or person
Institute
R24 Liver Conference
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Department of Gastroenterology and Hepatology, Kansai Electric Power Hospital
Center for Digestive and Liver Diseases, Nara City Hospital
Department of Gastroenterology, Tenri Hospital
Center for Digestive and Liver Diseases, Japan Commnunity Health care Organization
Hoshigaoka Medical Center
Department of Gastroenterology and Endocrinology, Nara Hospital, Kinki University School of Medicine
Department of Gastroenterology, Yamato Koriyama Hospital
Department of Gastroenterology, Matsushita Memorial Hospital
Department of Gastroenterology and Hepatology, Kyoto Yamashiro General Medical Center
Department of Gastroenterology, Kyoto Kizugawa Hospital
Department of Gastroenterology, Mitsubishi Kyoto Hospital
Department of Gastroenterology and Hepatology, Uji Takeda Hospital
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 02 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2024 | Year | 09 | Month | 30 | Day |
Other
Other related information
Comparison between IFN-free and IFN-based therapy in hepatitis C patients: risk for hepatocellular carcinoma.
Management information
Registered date
| 2015 | Year | 04 | Month | 29 | Day |
Last modified on
| 2016 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020105
