A Phase 3 study of the digital therapeutics CA-NASH in patients with Nonalcoholic Steatohepatitis (NASH)

JRCT ID: jRCT2032230595

Registered date:26/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Non-alcoholic Steatohepatitis
• Date of first enrollment: 26/01/2024
• Target sample size: 346
• Study type: Interventional

Intervention(s)

Intervention group:
CA-NASH (patient app) adjuncts to treatment from doctor by using CA-NASH (doctor app) for 48 weeks.

Control group:
record daily weight on weight log sheet and receive treatment with lifestyle modification checklist.

Outcome(s)

• Primary Outcome: Proportion of participants who achieve improvement from NASH to non-NASH without worsening of fibrosis [Time Frame: baseline and 48 weeks]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.
(10) Have a habit of drinking more than 20 g/day (pure ethanol equivalent) for women and 30 g/day (pure ethanol equivalent) for men.
(11) Subjects who have been newly prescribed/changed the dosage of/ discontinued vitamin E, pioglitazone, SGLT2 inhibitors, GLP-1 receptor agonists, Mazindol, HMG-CoA reductase inhibitors, pemafibrate, ezetimibe, angiotensin II receptor blockers (ARB), ACE inhibitors, Bofu Tongsang, or Oshibagoto within 90 days prior to consent.
(12) History of undergoing or scheduled to undergo bariatric surgery.
(13) Subjects who cannot be safely performed the liver biopsy (platelet count of less than 10 x 10-4/microliter or prothrombin time of less than 70%, etc. within 180 days prior to consent or visit 1).
(14) Pregnant, lactating, or female subjects who wish to get pregnant during the study period.
(15) Subjects who have received interventions in other clinical trials within 90 days prior to consent.
(16) Subjects who have previously participated in a the clinical trial (Ph-2 study) of this product.
(17) Judged to be inappropriate as a participant by the investigator or subinvestigator.

Related Information

• Primary Sponsor: Uechi Tatsuya
• Secondary Sponsor: Sawai Group Holdings Co., Ltd.