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Main
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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. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000003804 |
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Date of registration:
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25/06/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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
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Scientific title:
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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 - Steroid resuming study after serological relapse in AIP |
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Date of first enrolment:
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2010/05/01 |
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Target sample size:
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20 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004591 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not applicable
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Countries of recruitment
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Japan
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Contacts
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Name:
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Kenji
Hirano |
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Address:
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7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
1138654
Japan |
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Telephone:
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03-3815-5411 |
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Email:
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khirano-tky@umin.ac.jp |
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Affiliation:
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University of Tokyo Clinical Research Support Center |
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Name:
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Kenji
Hirano |
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Address:
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7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Japan |
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Telephone:
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03-3815-5411 |
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Email:
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khirano-tky@umin.ac.jp |
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Affiliation:
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University of Tokyo Department of Gastroenterology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: Patients who do not give their informed consent are excluded.
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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autoimmune pancreatitis
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Intervention(s)
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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.
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Primary Outcome(s)
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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.
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Secondary Outcome(s)
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Morphological change of pancreas Pancreatic endocrine function Occurrence of malignancy Survival time
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Source(s) of Monetary Support
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none
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Ethics review
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Status: YES
Approval date:
Contact:
Tikenjimu-tokyo@umin.ac.jp
Tokyo university clinical research promoting center
03-5800-8743
Tikenjimu-tokyo@umin.ac.jp
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/12/2013 |
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URL:
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