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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000002177
Receipt No. R000002671
Scientific Title Prospective randomized controlled trial Comparing Peg-IFN alpha-2a monotherapy versus Peg-IFN alpha-2a +ribavirin combination therapy after curative ablation for HCV-positive Hepatocellular Carcinoma
Date of disclosure of the study information 2009/07/10
Last modified on 2015/07/10

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Basic information
Public title Prospective randomized controlled trial Comparing Peg-IFN alpha-2a monotherapy versus Peg-IFN alpha-2a +ribavirin combination therapy after curative ablation for HCV-positive Hepatocellular Carcinoma
Acronym Comparing Peg-IFN alpha-2a(+RBV) for HCV-positive hepatocellular carcinoma patients after curative ablation.
Scientific Title Prospective randomized controlled trial Comparing Peg-IFN alpha-2a monotherapy versus Peg-IFN alpha-2a +ribavirin combination therapy after curative ablation for HCV-positive Hepatocellular Carcinoma
Scientific Title:Acronym Comparing Peg-IFN alpha-2a(+RBV) for HCV-positive hepatocellular carcinoma patients after curative ablation.
Region
Japan

Condition
Condition Chronic hepatitis C
Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety and the efficacy of Peg-IFN alpha-2a monotherapy and Peg-IFN alpha-2a +ribavirin combination therapy after curative ablation for HCV-positive hepatocellular carcinoma
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes Disease-free survival rates
2.5-year survival rates
3.Safety
Key secondary outcomes 1. Disease-free survival rates (each groups)
2. Changes in the serum HCV RNA level
3. Changes in the serum alanine aminotransferase level

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation NO
Institution consideration Institution is considered as a block.
Blocking YES
Concealment Central registration

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 peginterferon alfa-2a monotherapy peginterferon alfa-2a 180microgram(12W) +90microgram(84W):HCV-RNA>=2log drop
Interventions/Control_2 peginterferon alfa-2a in combination with ribavirin:peginterferon alfa-2a 180microgram(12W) +90microgram(84W)+Ribavirin5.5mg/kg 48w(13-60w):HCV-RNA>=2log drop
Interventions/Control_3 peginterferon alfa-2a monotherapy peginterferon alfa-2a 180microgram(12W) +90microgram(84W):HCV-RNA<=2log drop
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

Not applicable
Gender Male and Female
Key inclusion criteria 1. Patient with HCV-positive HCC which were curativelty treated with RFA or PEIT
2. Neutrophil>1,500/mm3, Platelet count>70,000/mm3, and Hemoglobin > 10.0/dL
3. Patient who was explained about the study, understood it, and gave the consent form
Key exclusion criteria Patient with
1.pregnant or lactating women and women who may be pregnant
2. a man who can not avoid conception during administration of ribavirin and until 6 month after the end ribavirin treatment
3. allergic to ribavirin or nucleoside analogues
4.hemoglobinopathy(thalassemia, sickle cell disease)
5.an uncontrollable heart trouble (myocardial infarction, heart failure, or arrhythmia)
6.an poorly controlled diabetes mellitus and hypertension
7. severe renal disease, Ccr <50ml/min
8. severe depression or psychosomatic disorders
9 .liver disease such as autoimmune hepatitis
10.clinical laboratory date does not meet selection criterion
11. drug allergy against interferon
Target sample size 95

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazushi Numata
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57,Urafune,Minami-ku,Yokohama City 232-0024, Japan
TEL 045-261-5656
Email kz-numa@urahp.yokohama-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akito Nozaki
Organization Yokohama City University Medical Center
Division name Gastroenterological Center
Zip code
Address 4-57,Urafune,Minami-ku,Yokohama City 232-0024, Japan
TEL 045-261-5656
Homepage URL
Email akino@yokohama-cu.ac.jp

Sponsor
Institute Yokohama City University Medical Center
Gastroenterological Center
Institute
Department

Funding Source
Organization None
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
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 横浜市立大学附属市民総合医療センター(神奈川県)
神奈川県立がんセンター(神奈川県)

Other administrative information
Date of disclosure of the study information
2009 Year 07 Month 10 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
2008 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 06 Month 01 Day
Last follow-up date
2016 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2009 Year 07 Month 10 Day
Last modified on
2015 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002671

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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