jRCT2032230595进行中（未招募）不适用
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)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 346
- 主要终点
- Proportion of participants who achieve improvement from NASH to non-NASH without worsening of fibrosis
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Proportion of participants who achieve improvement from NASH to non-NASH without worsening of fibrosis
时间窗: baseline and 48 weeks
Proportion of participants who achieve improvement from NASH to non-NASH without worsening of fibrosis
次要结局
未报告次要终点
研究者
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