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An Open-label Single-arm Prospective Study of Continuous Intervention with Designated Treatment Application for NASH (Non-Alcoholic Steatohepatitis) Patients

Phase 2
Conditions
non-alcoholic steatohepatitis
Registration Number
JPRN-UMIN000029835
Lead Sponsor
The University of Tokyo Hospital
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
20
Inclusion Criteria

Not provided

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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