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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000022959
Receipt No. R000026463
Scientific Title Hepato-protective effect of polaprezinc for patients with autoimmune hepatitis
Date of disclosure of the study information 2016/06/30
Last modified on 2020/07/03

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Basic information
Public title Hepato-protective effect of polaprezinc for patients with autoimmune hepatitis
Acronym Hepato-protective effect of polaprezinc
Scientific Title Hepato-protective effect of polaprezinc for patients with autoimmune hepatitis
Scientific Title:Acronym Hepato-protective effect of polaprezinc
Region
Japan

Condition
Condition Autoimmune hepatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To ilucidate the hepato-protective effect of plaprezinc for patients with autoimmune hepatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Improvement of hepatic functional reserve after continuous intake of polaprezinc
Key secondary outcomes Improvement of hepatic fibrosis marker

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 1) Patients obtained written informed consent
2) Patients with peptic ulcer
3) Patients with autoimmune hepatitis
Key exclusion criteria 1) Patients with oral intake difficulty
2) Patients with severe digestive disease
3) Pregnant woman, lactating woman, or a woman suspected of pregnancy
4) Patients with severe allergic reaction
5) Patients with drug abuse or psycological disorders
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KEI MORIYA
Organization Nara Medical University
Division name Third Department of Internal Medicine
Zip code
Address 840 Shijo-cho, Kashihara, Nara, JAPAN
TEL 0744-22-3051
Email moriyak@naramed-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name KEI MORIYA
Organization Nara Medical University
Division name Third Department of Internal Medicine
Zip code
Address 840 Shijo-cho, Kashihara, Nara, JAPAN
TEL 0744-22-3051
Homepage URL
Email moriyak@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Self funding
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 30 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 No longer recruiting
Date of protocol fixation
2015 Year 06 Month 25 Day
Date of IRB
2016 Year 02 Month 24 Day
Anticipated trial start date
2016 Year 06 Month 30 Day
Last follow-up date
2019 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study of evaluating the hepato-protective effect of polaprezinc for patients with autoimmune hepatitis

Management information
Registered date
2016 Year 06 Month 30 Day
Last modified on
2020 Year 07 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026463

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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