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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000323
Receipt No. 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

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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
Email

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
Email yoshidah-2im@h.u-tokyo.ac.jp

Sponsor
Institute Department of Gastroenterology
University of Tokyo
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000417

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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