UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003798 |
|---|---|
| Receipt number | R000004576 |
| Scientific Title | Follow-up research on prognois of autoimmune pancreatitis after tapering steroid |
| Date of disclosure of the study information | 2010/06/25 |
| Last modified on | 2013/12/21 15:26:54 |
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Basic information
Public title
Follow-up research on prognois of autoimmune pancreatitis after tapering steroid
Acronym
AIP steroid tapering study
Scientific Title
Follow-up research on prognois of autoimmune pancreatitis after tapering steroid
Scientific Title:Acronym
AIP steroid tapering study
Region
| Japan |
Condition
Condition
autoimmune pancreatitis
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective is the evaluation of safety after tapering and ceasing steroid in the patients who received steroid therapy for more than three years.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of no relapse, clinical relapse, and serological relapse in three years after tapering steroid
Key secondary outcomes
Morphological change of pancreas
Pancreatic endocrine function
Occurrence of malignancy
Survival time
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who meet asian diagnostic criteria of autoimmune pancreatitis
2) Patients who have received steroid maintenance therapy(<7.5mg prednisolone/day) for more than three years
3) Patients whose abdominal and chest CT performed within 6months show no active extrapancreatic lesions related to autoimmune pancreatitis.
4) Patients whose IgG is below 1600 mg/dl at least for one year
5) Patients whose serum amylase and lipase are not abnormally high. Patiens whose amylase is high, but p-amylase is not high are allowed to join this research.
6) Patients whose KL-6 is normal.
7) Patients whose TSH is below 10 uIU/ml.
8) Patients who are 20 years old or older.
9) Patients who give written informed consent after receiving enough explanation about the present research.
Key exclusion criteria
1) Patients who need steroid therapy for other diseases than autoimmune pancreatitis
2)Patients with past history of hospitalization due to relapse during maintenance steroid therapy
3) Patients whom doctors in charge judged that the entry is inadequate
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenji Hirano |
Organization
University of Tokyo
Division name
Department of Gastroenterology
Zip code
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
University of Tokyo
Division name
Clinical Research Support Center
Zip code
Address
TEL
03-3815-5411
Homepage URL
Sponsor or person
Institute
Department of Gastroenterology, University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
none
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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 25 | 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
21 patients with AIp were enrolled.
Clinical relapse was observed in 8.
Serological relapse without clinical relapse was observed in 5.
There was not any relapse in 8.
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
Terminated
Date of protocol fixation
| 2010 | Year | 04 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Patients are schduled to be followed for 3 years after starting tapering steroid.
The outcomes are classified into 3 groups,namely, "no relapse", "clinical relapse", and "serological relapse".
Management information
Registered date
| 2010 | Year | 06 | Month | 21 | Day |
Last modified on
| 2013 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004576
| 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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| Registered date | File name |
