World Health Organization site
Skip Navigation Links

Main
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-UMIN000022633
Date of registration: 06/06/2016
Prospective Registration: Yes
Primary sponsor: Osaka University
Public title: Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis.
Scientific title:
Date of first enrolment: 2016/06/06
Target sample size: 20
Recruitment status: Pending
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025723
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Japan
Contacts
Name: Takahiro Suda   
Address:  2-2 Yamadaoka, Suita, Osaka, Japan Japan
Telephone: 06-6879-3621
Email: mm2043st@gh.med.osaka-u.ac.jp
Affiliation:  Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Name: Tetsuo Takehara   
Address:  2-2 Yamadaoka, Suita, Osaka, Japan Japan
Telephone: 06-6879-3621
Email: office@gh.med.osaka-u.ac.jp
Affiliation:  Osaka University Graduate School of Medicine Department of Gastroenterology and Hepatology
Key inclusion & exclusion criteria
Inclusion criteria: 1) Asymptomatic and untreated patients with AIP diagnosed on the basis of the diagnostic criterion of AIP 2011 published by Japan Pancreas Society
2) Age of 20 and more
3) ECOG performance status of 0 or 1
4) Written informed consent

Exclusion criteria: 1) Patients who have already administered steroid and/or immunosuppressive drugs
2) Severe drug hypersensitivity
3) Active infection
4) Infection of HBV (patients with HBc antigen-positive or with HBs antibody-positive, or patients previously unvaccinated against HBV with HBs antibody-positive alone)
5) Patients who require the treatment of cerebrovascular or cardiovascular disorder
6) Patients with uncontrollable diabetes mellitus
7) Patients with uncontrollable hypertension
8) Patients with severe mental disorder
9) Patients with severe cataract or glaucoma
10) Patients with severe renal disorder
11) Patients with severe lung disorder
12) Patients with severe liver disorder
13) Patients with severe osteoporosis
14) Past history of pancreatectomy
15) Pregnant or lactating women, or women with suspected pregnancy
16) Patients seems inadequate for this study judged by investigators


Age minimum: 20years-old
Age maximum: Not applicable
Gender: Male and Female
Health Condition(s) or Problem(s) studied
autoimmune pancreatitis
Intervention(s)
Steroid treatment (total 56 weeks)

Induction ~ 4 weeks : Prednisolone 10mg/day
4 weeks ~ 48 weeks : Prednisolone 5mg/day
48 weeks ~ 52 weeks : Prednisolone 2.5mg/day
52 weeks ~ 56 weeks : Prednisolone 1mg/day
Primary Outcome(s)
The sequential change of pancreatic exocrine function
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Osaka University
Secondary Sponsor(s)
Ethics review
Status:
Approval date:
Contact:
Results
Results available:
Date Posted:
Date Completed:
URL:
Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.
Copyright - World Health Organization - Version 3.6 - Version history