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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-UMIN000003804
Date of registration: 25/06/2010
Prospective Registration: No
Primary sponsor: Department of Gastroenterology, University of Tokyo
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
Scientific title:
Date of first enrolment: 2010/05/01
Target sample size: 20
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004591
Study type:  Interventional
Study design:  Parallel Randomized  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: Kenji Hirano   
Address:  7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan
Telephone: 03-3815-5411
Email: khirano-tky@umin.ac.jp
Affiliation:  University of Tokyo Clinical Research Support Center
Name: Kenji Hirano   
Address:  7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan Japan
Telephone: 03-3815-5411
Email: khirano-tky@umin.ac.jp
Affiliation:  University of Tokyo Department of Gastroenterology
Key inclusion & exclusion criteria
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.
Exclusion criteria: Patients who do not give their informed consent are excluded.

Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
autoimmune pancreatitis
Intervention(s)
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.
Resuming or increasing prednisolone is not planned. Patients during the course of tapering prednisolone continue to taper the dose until its complete cessation.
Primary Outcome(s)
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.
Secondary Outcome(s)
Morphological change of pancreas
Pancreatic endocrine function
Occurrence of malignancy
Survival time
Secondary ID(s)
Source(s) of Monetary Support
none
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
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