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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000030207
Receipt No. R000034504
Scientific Title The effect of alpha-defensin on patients with chronic pancreatitis
Date of disclosure of the study information 2017/12/01
Last modified on 2017/12/01

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Basic information
Public title The effect of alpha-defensin on patients with chronic pancreatitis
Acronym Chronic pancreatitis and alpha-defensin
Scientific Title The effect of alpha-defensin on patients with chronic pancreatitis
Scientific Title:Acronym Chronic pancreatitis and alpha-defensin
Region
Japan

Condition
Condition Chronic pancreatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate an effect of alpha-defensin on pathogenesis in patients with chronic pancreatitis
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The relationship between chronic pancreatitis and alpha-defensin in stool and blood.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Chronic pancreatitis
Key exclusion criteria Informed consent was not obtained
Severe coagulopathy
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazumichi Kawakubo
Organization Hokkaido University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address Kita14 Nishi5, Kita-ku, Sapporo, Japan
TEL 0117161161
Email kkawakubo-gi@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumichi Kawakubo
Organization Hokkaido University Hospital
Division name Gastroenterology and Hepatology
Zip code
Address Kita14 Nishi5, Kita-ku, Sapporo, Japan
TEL 0117161161
Homepage URL
Email kkawakubo-gi@umin.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Self-funding
Organization
Division
Category of Funding Organization Other
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
2017 Year 12 Month 01 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 Open public recruiting
Date of protocol fixation
2016 Year 08 Month 29 Day
Date of IRB
Anticipated trial start date
2017 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2017 Year 12 Month 01 Day
Last modified on
2017 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034504

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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