UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002177 |
|---|---|
| Receipt number | 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 13:25:06 |
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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
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
akino@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Medical Center
Gastroenterological Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002671
