UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022585 |
|---|---|
| Receipt number | R000026034 |
| Scientific Title | Interferon-free HCV eradication after curative treatment of hepatocellular carcinoma Gastroenterologist of Tokyo university Outsiders (GTO) Study Group |
| Date of disclosure of the study information | 2016/06/05 |
| Last modified on | 2023/06/08 09:45:59 |
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Basic information
Public title
Interferon-free HCV eradication after curative treatment of hepatocellular carcinoma
Gastroenterologist of Tokyo university Outsiders (GTO)
Study Group
Acronym
iHOP study
Scientific Title
Interferon-free HCV eradication after curative treatment of hepatocellular carcinoma
Gastroenterologist of Tokyo university Outsiders (GTO)
Study Group
Scientific Title:Acronym
iHOP study
Region
| Japan |
Condition
Condition
HCV related HCC patients after curative treatment of HCC
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the safety and efficacy of IFN free treatment for HCV positive HCC patients after curative treatment of HCC.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SVR of IFN free treatment after 24 weeks of treatment (SVR24)
Key secondary outcomes
HCC reccurence
Liver and kidney function
Safety of treatment
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
IC acheved
HCV positive HCC patients after curative treatment of HCC
Key exclusion criteria
Alergic for using drugs
Decompaseted cirrhotic patients
Not suitable for IFN free treatment
Pregnant patients
Not suitable for the treatment judged by Dr. in charge
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hideo |
| Middle name | |
| Last name | Yoshida |
Organization
Japanese Red Cross Medical Center
Division name
Gastroenterology and Hepatology
Zip code
150-8935
Address
4-1-22 Hiro-o Shibuya-ku Tokyo Japan
TEL
03-3400-1311
yoshidahiderug@gmail.com
Public contact
Name of contact person
| 1st name | Hideo |
| Middle name | |
| Last name | Yoshida |
Organization
Japanese Red Cross Medical Center
Division name
Gastroenterology and Hepatology
Zip code
150-8935
Address
4-1-22 Hiro-o Shibuya-ku Tokyo Japan
TEL
03-3400-1311
Homepage URL
yoshidahiderug@gmail.com
Sponsor or person
Institute
Japanese Red Cross Medical Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Red Cross Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japanese Red Cross Medical Center
Address
4-1-22 Hiroo Shibuyaku Tokyo Japan
Tel
0334001311
yoshidahiderug@gmail.com
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
| 2016 | Year | 06 | Month | 05 | 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
56
Results
DAA treatment after HCC treatment was safe
Results date posted
| 2022 | Year | 12 | Month | 08 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
Data collection in progress
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
No longer recruiting
Date of protocol fixation
| 2016 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2016 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
End of enrollment.
Observation is on going.
Management information
Registered date
| 2016 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026034
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
