UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000029835
Receipt number 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 2023/05/12 13:51:52

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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 Masaya
Middle name
Last name Sato

Organization

The University of Tokyo Hospital

Division name

Department of Clinical Laboratory Medicine (Department of Gastroenterology)

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku

TEL

0338155411

Email

masayasato0407@gmail.com


Public contact

Name of contact person

1st name Masaya
Middle name
Last name Sato

Organization

The University of Tokyo Hospital

Division name

Department of Clinical Laboratory Medicine (Department of Gastroenterology)

Zip code

113-8655

Address

7-3-1, Hongo, Bunkyo-ku

TEL

0338155411

Homepage URL

http://park.itc.u-tokyo.ac.jp/livercancer/

Email

masayasato0407@gmail.com


Sponsor or person

Institute

The University of Tokyo Hospital

Institute

Department

Personal name



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

The University of Tokyo Hospital

Address

7-3-1, Hongo, Bunkyo ku

Tel

03-3815-5411

Email

CReSjimu-tokyo@umin.ac.jp


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

https://jrct.niph.go.jp/latest-detail/jRCTs032180372

Publication of results

Published


Result

URL related to results and publications

https://journals.lww.com/ajg/Fulltext/9900/Impact_of_a_Novel_Digital_Therapeutics_System_on.576.aspx

Number of participants that the trial has enrolled

20

Results

After the 48-week DTx intervention, improvement of the NAS was observed in 68.4% (13/19) of patients. The mean change in the NAS from the baseline to the end of the intervention was -2.05 (p = 0.007 as compared with the threshold of -0.7).A decrease of the NAS by mora than 2 points was achieved in 11 (57.9%). The average weight loss at the end of the intervention was 8.3% (p < 0.001). Reduction of the fibrosis stage was observed in 58.3% when the analysis was limited to patients with stage F2/3 fibrosis.

Results date posted

2023 Year 05 Month 12 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

The mean age of patients was 52.16 years, and male patients accounted for 52.6% (10/19) of all the patients. The mean BMI of the patients was 32.04. A total of 7 (36.8%) patients had fibrosis stage F1, 6 (31.6%) had stage F2, and 6 (31.6%) had stage F3; the mean NAS was 5.00.

Participant flow

We prospectively screened 29 patients who underwent liver biopsy for the evaluation of NAFLD between March 1, 2018, and November 30, 2020; finally, 19 patients were included in the analyses

Excluded (n=10)
1Not meeting inclusion criteria (n=7)
2No Wi-Fi or Bluetooth access at home (n=2)
3Protocol deviation (n=1)

Adverse events

During the study, a total of 6 patients (31.6%) reported adverse event(s). There were two serious adverse events: one patient was admitted to hospital for testicular cancer, and one for variant angina. None of the adverse events in the current study were considered to be related to the DTx system, with the exception of myalgia in one case.

Outcome measures

The primary efficacy endpoint was change in the NAS without worsening of the liver fibrosis (worsening of liver fibrosis was defined as increase of the fibrosis stage by at least one level). The secondary endpoint included improvement of the NAS by at least 2 points or disappearance of hepatocyte ballooning, changes in other histological findings (fibrosis, steatosis, lobular inflammation, and ballooning), reduction of the body weight by at least 7%, which has been shown to be necessary for improvement of NASH, changes in the levels of liver enzymes, changes in the body weight, and lipid and glucose parameters. Safety endpoints included the incidence of adverse events after enrollment in the study. The following measures were used to evaluate the usage of the app and adherence to the recommendations: (1) mobile app engagement rate; (2) weight measurement rate; and (3) habit improvement rate. The mobile app engagement rate was calculated as the number of days that the app was used divided by the total duration (in days) of participation in the trial. The weight measurement rate was the number of days on which weight measurements were taken divided by the duration of the trial (48 weeks). The habit improvement rate was the number of behavioral goals achieved divided by the total number of action goals.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 11 Month 09 Day

Date of IRB

2018 Year 02 Month 07 Day

Anticipated trial start date

2018 Year 02 Month 08 Day

Last follow-up date

2021 Year 11 Month 30 Day

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

2023 Year 05 Month 12 Day



Link to view the page

Value
https://center6.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