UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003804 |
|---|---|
| Receipt number | 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 | 2023/07/02 23:30:14 |
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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 | Kenji |
| Middle name | |
| Last name | Hirano |
Organization
University of Tokyo
Division name
Department of Gastroenterology
Zip code
1138654
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
khirano-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Kenji |
| Middle name | |
| Last name | Hirano |
Organization
University of Tokyo
Division name
Clinical Research Support Center
Zip code
1138654
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
khirano-tky@umin.ac.jp
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
Tokyo university clinical research promoting center
Address
7-3-1,Bunkyo-ku, Hongo, Tokyo, Japan
Tel
03-5800-8743
Tikenjimu-tokyo@umin.ac.jp
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
| 2023 | Year | 07 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004591
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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