UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022633
Receipt number R000025723
Scientific Title Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis.
Date of disclosure of the study information 2016/06/06
Last modified on 2016/06/06 19:48:35

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Basic information

Public title

Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis.

Acronym

Usefulness of low-dose steroid treatment in patients with autoimmune pancreatitis.

Scientific Title

Efficacy and safety of low-dose steroid treatment in asymptomatic patients with autoimmune pancreatitis.

Scientific Title:Acronym

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



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



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

1st name
Middle name
Last name Tetsuo Takehara

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


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

1st name
Middle name
Last name Takahiro Suda

Organization

Osaka University Graduate School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

2-2 Yamadaoka, Suita, Osaka, Japan

TEL

06-6879-3621

Homepage URL


Email

mm2043st@gh.med.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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


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

Preinitiation

Date of protocol fixation

2016 Year 05 Month 18 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025723


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name