UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis.
Title of the study (Brief title)	Usefulness of low-dose steroid treatment in patients with autoimmune pancreatitis.
Region	Japan

Condition
Condition	autoimmune pancreatitis
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to evaluate the efficacy of low-dose steroid treatment for asymptomatic patients with autoimmune pancreatitis (AIP) prospectively.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The sequential change of pancreatic exocrine function
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	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
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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
Key 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
Target sample size	20

Research contact person
Name of lead principal investigator	Tetsuo Takehara
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3621
Email	office@gh.med.osaka-u.ac.jp

Public contact
Name of contact person	Takahiro Suda
Organization	Osaka University Graduate School of Medicine
Division name	Department of Gastroenterology and Hepatology
Address	2-2 Yamadaoka, Suita, Osaka, Japan
TEL	06-6879-3621
Homepage URL
Email	mm2043st@gh.med.osaka-u.ac.jp

Sponsor
Institute	Osaka University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Osaka University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 06 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 05 Month 18 Day
Anticipated trial start date	2016 Year 06 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

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

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025723