UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007344 |
|---|---|
| Receipt number | 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 09:07:33 |
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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 ≤ 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
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
sumie_shyuuji@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008608
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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