Unique ID issued by UMIN | UMIN000029835 |
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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 |
An Open-label Single-arm Prospective Study of Continuous Intervention with Designated Treatment Application for NASH (Non-Alcoholic Steatohepatitis) Patients
A study of NASH treatment application for patients with non alcoholic steatohepatitis
An Open-label Single-arm Prospective Study of Continuous Intervention with Designated Treatment Application for NASH (Non-Alcoholic Steatohepatitis) Patients
A study of NASH treatment application for patients with non alcoholic steatohepatitis
Japan |
non-alcoholic steatohepatitis
Hepato-biliary-pancreatic medicine |
Others
NO
To investigate the efficacy of treatment aid application for non-alcoholic steatohepatitis
Efficacy
Exploratory
Phase II
Histological improvement of non-alcoholic steatohepatitis following 1 year therapeutic treatment with application
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
Treatment aid for non-alcoholic steatohepatitis application
20 | years-old | <= |
Not applicable |
Male and Female
patients with histologically diagnosed non-alcoholic who agree to participate in the study after enough explanation about the study.
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
20
1st name | Masaya |
Middle name | |
Last name | Sato |
The University of Tokyo Hospital
Department of Clinical Laboratory Medicine (Department of Gastroenterology)
113-8655
7-3-1, Hongo, Bunkyo-ku
0338155411
masayasato0407@gmail.com
1st name | Masaya |
Middle name | |
Last name | Sato |
The University of Tokyo Hospital
Department of Clinical Laboratory Medicine (Department of Gastroenterology)
113-8655
7-3-1, Hongo, Bunkyo-ku
0338155411
http://park.itc.u-tokyo.ac.jp/livercancer/
masayasato0407@gmail.com
The University of Tokyo Hospital
CureApp,Inc.
Other
The University of Tokyo Hospital
7-3-1, Hongo, Bunkyo ku
03-3815-5411
CReSjimu-tokyo@umin.ac.jp
NO
2017 | Year | 12 | Month | 31 | Day |
https://jrct.niph.go.jp/latest-detail/jRCTs032180372
Published
https://journals.lww.com/ajg/Fulltext/9900/Impact_of_a_Novel_Digital_Therapeutics_System_on.576.aspx
20
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.
2023 | Year | 05 | Month | 12 | Day |
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.
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)
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.
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.
Completed
2017 | Year | 11 | Month | 09 | Day |
2018 | Year | 02 | Month | 07 | Day |
2018 | Year | 02 | Month | 08 | Day |
2021 | Year | 11 | Month | 30 | Day |
2017 | Year | 11 | Month | 06 | Day |
2023 | Year | 05 | Month | 12 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033976
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