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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000029835
Receipt No. R000033976
Scientific Title An Open-label Single-arm Prospective Study of Continuous Intervention with Designated Treatment Application for NASH (Non-Alcoholic Steatohepatitis) Patients
Date of disclosure of the study information 2017/12/31
Last modified on 2018/04/18

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Basic information
Public title An Open-label Single-arm Prospective Study of Continuous Intervention with Designated Treatment Application for NASH (Non-Alcoholic Steatohepatitis) Patients
Acronym A study of NASH treatment application for patients with non alcoholic steatohepatitis
Scientific Title An Open-label Single-arm Prospective Study of Continuous Intervention with Designated Treatment Application for NASH (Non-Alcoholic Steatohepatitis) Patients
Scientific Title:Acronym A study of NASH treatment application for patients with non alcoholic steatohepatitis
Region
Japan

Condition
Condition non-alcoholic steatohepatitis
Classification by specialty
Hepato-biliary-pancreatic medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of treatment aid application for non-alcoholic steatohepatitis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Histological improvement of non-alcoholic steatohepatitis following 1 year therapeutic treatment with application
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
Device,equipment
Interventions/Control_1 Treatment aid for non-alcoholic steatohepatitis application
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 patients with histologically diagnosed non-alcoholic who agree to participate in the study after enough explanation about the study.
Key exclusion criteria 1.patients do not agree
2.patients who are regarded as difficult to use a smartphone
3.patients with viral hepatitis
4.patients diagnosed as autoimmune hepatitis
5.patients diagnosed as metabolic disease
6.patients who are histologically diagnosed as cirrhosis
7.patients with current or history of hepatocellular carcinoma
8.patients with condition that cannot be performed liver biopsy safely
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaya Sato
Organization The University of Tokyo Hospital
Division name Department of Clinical Laboratory Medicine (Department of Gastroenterology)
Zip code
Address 7-3-1, Hongo, Bunkyo-ku
TEL 03-3815-5411
Email satoma-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaya Sato
Organization The University of Tokyo Hospital
Division name Department of Clinical Laboratory Medicine (Department of Gastroenterology)
Zip code
Address 7-3-1, Hongo, Bunkyo-ku
TEL 03-3815-5411
Homepage URL
Email satoma-tky@umin.ac.jp

Sponsor
Institute CureApp,Inc.
Institute
Department

Funding Source
Organization CureApp,Inc.
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 31 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
2017 Year 11 Month 09 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

Management information
Registered date
2017 Year 11 Month 06 Day
Last modified on
2018 Year 04 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033976

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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