UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005650 |
|---|---|
| Receipt number | R000003963 |
| Scientific Title | Immunohistochemical Study Using IgG4 Antibody on Liver Tissue in Autoimmune hepatitis. Dose IgG4-related cholangitis exist in Autoimmune hepatitis? |
| Date of disclosure of the study information | 2011/05/26 |
| Last modified on | 2011/05/26 10:24:20 |
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Basic information
Public title
Immunohistochemical Study Using IgG4 Antibody on Liver Tissue in Autoimmune hepatitis. Dose IgG4-related cholangitis exist in Autoimmune hepatitis?
Acronym
IgG4 Staining on Liver Tissue in Autoimmune hepatitis.
Scientific Title
Immunohistochemical Study Using IgG4 Antibody on Liver Tissue in Autoimmune hepatitis. Dose IgG4-related cholangitis exist in Autoimmune hepatitis?
Scientific Title:Acronym
IgG4 Staining on Liver Tissue in Autoimmune hepatitis.
Region
| Japan |
Condition
Condition
autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, chronic hepatitis B, chronic hepatitis C
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is examined whether IgG4-related sclerosing cholabgitits is miss diagnosed in autoimmune hepatitis or not.
Basic objectives2
Others
Basic objectives -Others
Confirmation of the past diagnosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Significant difference authorization of the case diagnosed as IgG4-related sclerosing cholabgitits in autoimmune hepatitis and control group.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Cases of autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, chronic hepatitis B and chronic hepatitis C.
Key exclusion criteria
other diseases
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiki Yamamoto |
Organization
Nihon University School of Medicine
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
Address
1-8-13 Kanda-Surugadai Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Surugadai Nihon University Hospital
Division name
Division of Gastroenterology and Hepatology, Department of Medicine
Zip code
Address
1-8-13 Kanda-Surugadai Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Surugadai Nihon University Hospital
Institute
Department
Personal name
Funding Source
Organization
Division of Gastroenterology and Hepatology, Department of Medicine
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
| 2011 | Year | 05 | Month | 26 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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 | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 11 | 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
Immunostaining is examined in the liver tissue samples.
Management information
Registered date
| 2011 | Year | 05 | Month | 26 | Day |
Last modified on
| 2011 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003963
