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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000203
Receipt No. 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

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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
Email 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
Email satoken@gunma-u.ac.jp

Sponsor
Institute Gunma Liver Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000262

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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