UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000323 |
|---|---|
| Receipt number | R000000417 |
| Scientific Title | Prospective Randomized Controlled trial of low dose long term Peg-Interferon alpha-2a treatment after curative ablation for Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2006/03/01 |
| Last modified on | 2017/06/22 15:14:30 |
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Basic information
Public title
Prospective Randomized Controlled trial of low dose long term Peg-Interferon alpha-2a treatment after curative ablation for Hepatocellular Carcinoma
Acronym
Low dose Peg-IFN after Ablation for HCC
Scientific Title
Prospective Randomized Controlled trial of low dose long term Peg-Interferon alpha-2a treatment after curative ablation for Hepatocellular Carcinoma
Scientific Title:Acronym
Low dose Peg-IFN after Ablation for HCC
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 low dose and long term Peg-Interferon alpha-2a treatment after curative ablation for hepatocellular carcinoma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. HCC recurent rate
2. Time to recurrence
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Low dose and long term treatment with Peg-Interferon alpha-2a
Interventions/Control_2
Conservertive treatment with drugs like UDCA
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient with HCC which were curatively treated with RFA.
2.Patient who tried the treatment for eradication of HCV, which was failed.
3.Neutrophil>750/mm3, Platelet, count>50,000, and Hemoglobin>8.5g/dL
4.Patient who was explained about the study, understood it, and gave the consent form.
Key exclusion criteria
Patient with
1.Drug allergy against Interferon.
2.Allergy against biological drugs.
3.Poorly controlled heart disease.
4.Extrahepatic metastasis of HCC
5.Active cancer of other organ.
6.Severe renal dysfunction; BUN>30mg/dL, or Cre>2.0mg/dL
7.on the herb treatment
8.other chronic liver disease like AIH or hepatitisB
9.Depression
10.on other clinical trial
11. any reason which medical doctor regard the patient as unsuitable for this test.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Omata, Masao |
Organization
University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshida, Hideo |
Organization
University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
TEL
Homepage URL
yoshidah-2im@h.u-tokyo.ac.jp
Sponsor or person
Institute
Department of Gastroenterology
University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology
University of Tokyo
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
Other administrative information
Date of disclosure of the study information
| 2006 | Year | 03 | Month | 01 | 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
No longer recruiting
Date of protocol fixation
| 2006 | Year | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2006 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 01 | 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
| 2006 | Year | 02 | Month | 04 | Day |
Last modified on
| 2017 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000417
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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