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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000003804
Receipt No. R000004591
Scientific Title Randomized controlled trial which examines whether resuming steroid can prevent clinical relapse in the patients with asymptomatic high levels of serum IgG after ceasing steroid therapy for autoimmune pancreatitis
Date of disclosure of the study information 2010/06/25
Last modified on 2016/06/22

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Basic information
Public title Randomized controlled trial which examines whether resuming steroid can prevent clinical relapse in the patients with asymptomatic high levels of serum IgG after ceasing steroid therapy for autoimmune pancreatitis
Acronym Steroid resuming study after serological relapse in AIP
Scientific Title Randomized controlled trial which examines whether resuming steroid can prevent clinical relapse in the patients with asymptomatic high levels of serum IgG after ceasing steroid therapy for autoimmune pancreatitis
Scientific Title:Acronym Steroid resuming study after serological relapse in AIP
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 purpose is to clarify whether it is reasonable to resume steroid for serological relapse in the patients with AIP after ceasing steroid therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Patients with AIP, who show serological relapse (defined as IgG>1600mg/dl) after their maintenance steroid dose is tapered or ceased, are enrolled in this study. They are divided into 2 groups, that is, 1) steroid resuming group, and 2) obsevation group. The main outcome is to clarify frequency and severity of pancreatic or extrapancreatic clinical relapse in each group within 3 years.
Key secondary outcomes Morphological change of pancreas
Pancreatic endocrine function
Occurrence of malignancy
Survival time

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control No treatment
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Prednisolone at a dose of 10mg/day is started. The dose is taperd by 2.5mg every 8-10 weeks until reaching 5mg/day.
Maintenance therapy at a dose of 5 mg/day is continued.
Interventions/Control_2 Resuming or increasing prednisolone is not planned. Patients during the course of tapering prednisolone continue to taper the dose until its complete cessation.
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 Among patients who joined our clinical trial "Follow-up research on prognois of autoimmune pancreatitis after tapering steroid (UMIN000003798)", those who show serological relapse (defined as IgG>1600 mg/dl) during tapering steroid or after its cessation are enrolled in this study.
Key exclusion criteria Patients who do not give their informed consent are excluded.
Target sample size 20

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 03-3815-5411
Email khirano-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Hirano
Organization University of Tokyo
Division name Clinical Research Support Center
Zip code
Address 7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL 03-3815-5411
Homepage URL
Email khirano-tky@umin.ac.jp

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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results Four patients were enrolled.
Two patients each were assigned to steroid resuming group, and no resuming group, respectively. Two patients in steroid resuming group did not reveal clinical relapse, but the others revealed clinical relapse.
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 Enrolling by invitation
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 Since "follow-up research on prognois of autoimmune pancreatitis after tapering steroid (UMIN 3798)" was terminated, this study was also terminated in conjunction with it.

Management information
Registered date
2010 Year 06 Month 22 Day
Last modified on
2016 Year 06 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004591

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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