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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003798
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Gastroenterology, University of Tokyo
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004576

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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