JPRN-jRCTs041200011已完成未知
Prospective, multi-center, Open-label, Randomized, omega-3-acid ethyl ester-controlled TRial to Assess the Impact of The pemafibrate on liver function in hypertriglyceridemia patients with non-alcoholic fatty liver disease
Sumida Yoshio0 个研究点目标入组 80 人开始时间: 2020年5月25日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Subjects who meet all of the following criteria are included in this study:
- •1. Subjects whose fasting TG is 150 mg/dL or higher and less than 500 mg/dL within 12 weeks before giving their consent.
- •2. Subjects who are diagnosed as steatosis by abdominal ultrasound test within 6 months before giving their consent.
- •3. Male subjects whose ALT is higher than 40 IU/L or female subjects whose ALT is higher than 30 IU/L within 12 weeks before giving their consent.
- •4. Male and female aged 20 years or older
- •5. Subjects who give their consent in a written form
排除标准
- •Subjects who fall into any of the following criteria are excluded from participating in the study:
- •1.Subjects whose ALT is 250 IU/L or higher
- •2. Subjects who are excessive drinkers (male subjects whose ethanol intake is 210 g/week or more, or female subjects whose ethanol intake is 140 g/week)
- •3. Subjects who use fibrates within 12 weeks before giving their consenting
- •4. Subjects who use omega-3 fatty acid agents or relevant supplements within 6 months before giving their consenting
- •5. Subjects who use prohibited drugs in this study (pioglitazone, vitamin E, SGLT2 inhibitors, GLP-1 receptor antagonists, study agent, control agent, or any drugs or supplements with the same indications) within 12 weeks before giving their consenting
- •6. Subjects whose BMI is less than 22 kg/m2
- •7. Subjects with unstable glycemic control (HbA1c within 12 weeks before giving their consent months is 8% or higher)
- •8. Subjects with hepatic cirrhosis
- •9. Subjects whose plasma creatinine is 1.5 mg/dL or higher
- •10. Subjects with cholelithiasis or biliary obstruction
- •11. Subjects who have chronic liver diseases with the following steatosis except NAFLD
- •i) viral hepatitis (hepatitis B, hepatitis C)
- •ii) autoimmune hepatitis (AIH)
- •iii) primary biliary cholangitis (PBC)
- •iv) primary sclerosing cholangitis (PSC)
- •v) drug-induced liver injury
- •vi) endocrine/metabolic hepatitis (hyperthyroidism, Wilson disease, hemochromatosis, or alpha1-antitrypsin deficiency)
- •12. Patients with malignant tumor or patients who are expected to have any recurrence of malignant tumor after the amelioration
- •13. Patients who underwent blood collection or blood donation of 200 mL or more within 12 weeks before giving their consent
- •14. Patients with history of severe drug hypersensitivity (such as anaphylactic shock)
- •15. Patients who are breastfeeding, pregnant, possibly pregnant, or planning to be pregnant
- •16. Patients who are participating in other interventional trials
- •17. Patients with history of hypersensitivity to, or who meet contraindication for the study agent or the control agent in this study
- •18. Patients who need legal representative for giving consent
- •19. Patients who are considered to be unsuitable for participating in this study by investigators
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