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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007344
Receipt No. R000008608
Scientific Title Pioglitazon and hepatocellular carcinoma with HCV infection
Date of disclosure of the study information 2012/03/01
Last modified on 2014/08/26

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Basic information
Public title Pioglitazon and hepatocellular carcinoma with HCV infection
Acronym Pioglitazon and hepatocellular carcinoma with HCV infection
Scientific Title Pioglitazon and hepatocellular carcinoma with HCV infection
Scientific Title:Acronym Pioglitazon and hepatocellular carcinoma with HCV infection
Region
Japan

Condition
Condition hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We evaluate whether pioglitazon inhibit recurrence after treatment in hepatocellular carcinoma patients with HCV infection.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes recurrence of hepatocellular carcinoma
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pioglitazone
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1)Hepatocellular carcinoma with HCV infection
(2)Hepatocellular carcinoma with three or fewer tumors each &#8804; 3 cm
(3)Patient with hepatocellular carcinoma underwent curative therapy
Key exclusion criteria (1)Patient with severe gastrointestinal stasis
(2)severe renal injury(creatinin>2.0mg/dL)
(3)Patient with esophageal varix
(4)Hepatocellular carcinoma with macroscopic vascular invasion
(5)Poorly differentiated hepatocellular carcinoma
(6)Patients with heart failure
(7)Liver cirrhosis with Child-Pugh grade C
(8)patients with type 1 diabetes mellitus
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shuji Sumie
Organization Kurume University School of
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume, Fukuoka
TEL 0942353311
Email sumie_shyuuji@kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shuji Sumie
Organization Kurume University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address sumie_shyuuji@kurume-u.ac.jp
TEL 0942353311
Homepage URL
Email sumie_shyuuji@kurume-u.ac.jp

Sponsor
Institute Kurume University School of Medicine
Institute
Department

Funding Source
Organization Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of Japan
Organization
Division
Category of Funding Organization
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
2012 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 Completed
Date of protocol fixation
2009 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 02 Month 21 Day
Last modified on
2014 Year 08 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008608

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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