UMIN-CTR Clinical Trial

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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