UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016070 |
|---|---|
| Receipt number | R000018176 |
| Scientific Title | Comparison of efficacy for suppression of hepatocellular carcinoma after antiviral treatment between interferon beta and ribavirin treatment and pegylated interferon alpha and ribavirin treatment |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2014/12/26 10:40:52 |
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Basic information
Public title
Comparison of efficacy for suppression of hepatocellular carcinoma after antiviral treatment between interferon beta and ribavirin treatment and pegylated interferon alpha and ribavirin treatment
Acronym
Efficacy of interferon beta and ribavirin treatment for suppression of hepatocellular carcinoma
Scientific Title
Comparison of efficacy for suppression of hepatocellular carcinoma after antiviral treatment between interferon beta and ribavirin treatment and pegylated interferon alpha and ribavirin treatment
Scientific Title:Acronym
Efficacy of interferon beta and ribavirin treatment for suppression of hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we compared the efficacy of suppression of hepatocellular carcinoma after antiviral treatment between interferon beta and ribavirin treatment and pegylated interferon alpha and ribavirin treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
We followed the occurence of hepatocellular carcinoma after antiviral treatments.
Key secondary outcomes
Virological response was evaluated.
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Interferon beta and ribavirin treatment group
Interventions/Control_2
Pegylated interferon alpha and ribavirin treatment group
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who were infected with hepatitis C virus.
Key exclusion criteria
Exclusion criteria for this study were: 1. presence of hepatocellular carcinoma, 2. shortening of treatment, 3. extension of treatment, 4. positivity of HIV or hepatitis B virus surface antigen, 5. severe depression, 6. hepatic decompensation, 7. excessive active alcohol consumption or drug abuse, 8. treatment with antiviral or immnosuppressive agents
Target sample size
800
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihiro Furusyo |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
0926425909
furusyo@gim.med.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norihiro Furusyo |
Organization
Kyushu University Hospital
Division name
Department of General Internal Medicine
Zip code
Address
3-1-1, Maidashi, Higashi-ku, Fukuoka
TEL
0926425909
Homepage URL
furusyo@gim.med.kyushu-u.ac.jp
Sponsor or person
Institute
Department of General Internal Medicine, Kyushu University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of General Internal Medicine, Kyushu University Hospital
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
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
九州大学病院（福岡県）、新小倉病院（福岡県）、新日鉄八幡病院（福岡県）、浜の町病院（福岡県）、北九州市立医療センター（福岡県）、福岡市民病院（福岡県）、小倉医療センター（福岡県）、九州医療センター（福岡県）、九州中央病院（福岡県）、千早病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | 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
Completed
Date of protocol fixation
| 2009 | Year | 01 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 01 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 27 | Day |
Last modified on
| 2014 | Year | 12 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018176
