JPRN-jRCT2032230595
Recruiting
Phase 3
A multicenter randomised open-label study to evaluate the efficacy and safety of the digital therapeutics CA-NASH in patients with Nonalcoholic Steatohepatitis (NASH) (Phase 3)
echi Tatsuya0 sites346 target enrollmentJanuary 26, 2024
Conditionson-alcoholic Steatohepatitis
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- on-alcoholic Steatohepatitis
- Sponsor
- echi Tatsuya
- Enrollment
- 346
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who meet all of the following criteria will be included.
- •(1\) 18 years of age or older at the time of the consent.
- •(2\) Able to understand and give written informed consent.
- •(3\) Have a diagnosis of NASH and meet all of the following criteria
- •Body mass index (BMI) \>\=25\.0 kg/m2 (Including BMI \>\=35\.0 kg/m2\)
- •Recommended weight loss through the guidance for lifestyle improvement
- •(4\)Use smartphone with iOS 16 or higher or Android version 10 or higher.
- •(5\)Able to fully understand the content of CA\-NASH and use the smartphone application.
Exclusion Criteria
- •Subjects who meet any of the following criteria shall not be included in this study.
- •(1\) Subjects with a positive HBs antigen or HCV\-RNA result at screening. Or patients with a positive HBs antigen or HCV\-RNA test result within 2 years prior to the screening.
- •(2\) Subjects with autoimmune hepatitis, primary cholangitis, or primary sclerosing cholangitis.
- •(3\) Subjects with metabolic diseases such as hemochromatosis and Wilson's disease (if already diagnosed by ceruloplasmin, alfa1\-antitrypsin, transferrin saturation, etc.).
- •(4\) Subjects with liver cirrhosis or suspected liver cirrhosis.
- •(5\) Coexisting hepatocellular carcinoma or have a history of treatment for hepatocellular carcinoma.
- •(6\) History of diagnosis and treatment of malignant tumors within 5 years prior to the consent (excluding cancers that can be cured by local treatment, such as basal cell cancer, squamous cell carcinoma, and intraepithelial carcinoma).
- •(7\) Subjects with secondary NASH (NASH associated with steroids and tamoxifen, NASH associated with endocrine disorders, NASH due to polycystic ovary syndrome, etc.).
- •(8\) Subjects with portal hypertension or signs of hepatic insufficiency (ascites accumulation, variceal hemorrhage, idiopathic bacterial peritonitis, hepatic encephalopathy) or with a history of such complications.
- •(9\) History of getting a liver transplant as a recipient.
Outcomes
Primary Outcomes
Not specified
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