UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000203 |
|---|---|
| Receipt number | R000000262 |
| Scientific Title | Prevention of hepatocellular carcinoma in patients with chronic hepatitis C and cirrhosis by pegylated IFN-alpha-2a after surgical resection or radiofrequency ablation |
| Date of disclosure of the study information | 2005/09/13 |
| Last modified on | 2015/08/30 09:52:28 |
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Basic information
Public title
Prevention of hepatocellular carcinoma in patients with chronic hepatitis C and cirrhosis by pegylated IFN-alpha-2a after surgical resection or radiofrequency ablation
Acronym
GLSG.2004.Pegasys
Scientific Title
Prevention of hepatocellular carcinoma in patients with chronic hepatitis C and cirrhosis by pegylated IFN-alpha-2a after surgical resection or radiofrequency ablation
Scientific Title:Acronym
GLSG.2004.Pegasys
Region
| Japan |
Condition
Condition
chronic hepatitis C,cirrhosis,hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
randomized controlled study of PEG-IFN-alpha-2a for prevention of hepatocellular carcinoma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevention of hepatocellular carcinoma
Key secondary outcomes
HCV-RNA,ALT,fibrosis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PEG-IFN-alpha2a
Interventions/Control_2
no treatment
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HCV-RNA(+) hepatocarcinoma
Child-Pugh A
3months after HCC treatment
Key exclusion criteria
ANC<750/mm3,Plt<50,000/mm3
Child-Pugh B,C
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8127
satoken@gunma-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ken Sato |
Organization
Gunma University Graduate School of Medicine
Division name
Department of Medicine and Molecular Science
Zip code
Address
3-39-22 Showa, Maebashi, Gunma 371-8511, Japan
TEL
027-220-8127
Homepage URL
satoken@gunma-u.ac.jp
Sponsor or person
Institute
Gunma Liver Study Group
Institute
Department
Personal name
Funding Source
Organization
Gunma Liver Study Group
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
| 2005 | Year | 09 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2003 | Year | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2003 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2005 | Year | 09 | Month | 13 | Day |
Last modified on
| 2015 | 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=R000000262
