UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014971 |
|---|---|
| Receipt number | R000017401 |
| Scientific Title | Comparison of DAAs(Direct Acting Antivirals) and interferon-based triple therapy for hepatitis C after treatment of hepatocelluler carcinoma. |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2018/08/30 15:15:09 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of DAAs(Direct Acting Antivirals) and interferon-based triple therapy for hepatitis C after treatment of hepatocelluler carcinoma.
Acronym
Antiviral therapy for HCV after treatment of hepatocelluler carcinoma.
Scientific Title
Comparison of DAAs(Direct Acting Antivirals) and interferon-based triple therapy for hepatitis C after treatment of hepatocelluler carcinoma.
Scientific Title:Acronym
Antiviral therapy for HCV after treatment of hepatocelluler carcinoma.
Region
| Japan |
Condition
Condition
Hepatitis C after treatment for hepatocelluler carcinoma.
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify the antiviral therapy for inhibition of recurrence after treatment for hepatocelluler carcinoma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of recurrence
survival rate
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) HCV genotype 1b
2) Neutrophil >=1,500 /mm3
PLT >= 75,000 /mm3
3) >=3 months post HCC treatment
4) CH or LC(Child-Pugh A)
5) within HCC stage 3
6) including post PSE/splenectomy cases
Key exclusion criteria
Patients judged by doctor that participation in the study is improper
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouji Joko |
Organization
Matsuyama Red Cross Hospital
Division name
Center for liver-Biliary-Pancreatic Diseases
Zip code
Address
1 Bunkyo-cho, Matsuyama-shi, EHIME
TEL
089-924-1111
Koujijoko@matsuyama.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshie Mashiba |
Organization
Matsuyama Red Cross Hospital
Division name
Center for liver-Biliary-Pancreatic Diseases
Zip code
Address
1 Bunkyo-cho, Matsuyama-shi, EHIME
TEL
089-924-1111
Homepage URL
matoshi@matsuyama.jrc.or.jp
Sponsor or person
Institute
Musashino Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
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
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
| 2014 | Year | 09 | Month | 01 | 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
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 | 08 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of DAAs(daclatasvir and asunaprevir) and interferon-based triple therapy for hepatitis C after treatment for hepatocelluler carcinoma in Red Cross Hospital in Japan.
Management information
Registered date
| 2014 | Year | 08 | Month | 27 | Day |
Last modified on
| 2018 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017401
