JPRN-jRCTs051220094招募中2 期
Efficacy and safety of imeglimin hydrochloride for non-alcoholic fatty liver disease with type 2 diabetes: single-center, single-arm phase II study - IMELD Study
Kitano Masayuki0 个研究点目标入组 27 人开始时间: 2022年9月15日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 27
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
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Patients with NAFLD.
- •(2)Patients with ALT value of 31U/L or higher.
- •(3)Patients with type 2 diabetes with HbA1c level of 6.5% or higher.
- •(4)Patients aged 18 years or older at the time of providing consent.
- •(5)Patients who have provided written consent to inclusion in this study.
排除标准
- •(1)Patients with a habit of drinking alcohol (30 g/day or more of ethanol for men, 20 g/day or more of ethanol for women).
- •(2)Patients diagnosed with viral hepatitis, with the exception of the following cases, which are allowed:
- •-Persistent virological response (SVR) after hepatitis C treatment.
- •-HCV-RNA is not detected even if HCV antibody is positive.
- •-The following cases of past hepatitis B virus infection:
- •-HBsAg negative and HBs antibody positive.
- •-HBsAg negative and HBc antibody positive.
- •(3)Patients diagnosed with drug-induced liver injury, autoimmune hepatitis, or primary biliary cholangitis.
- •(4)Patients with decompensated cirrhosis (Child-Pugh classification B or C).
- •(5)Patients with eGFR < 45mL/min/1.73m2.
- •(6)Patients with type 1 diabetes.
- •(7) Patients diagnosed with mitochondrial diabetes.
- •(8)Patients receiving corticosteroid treatment by oral administration or injection.
- •(9)Patients with severe ketosis or diabetic coma/precoma.
- •(10)Patients with malignant tumors, or who have been treated for malignant tumors within the past year (however, treatment history for basal cell carcinoma of the skin, squamous cell carcinoma in situ is acceptable).
- •(11)Patients who have started or changed vitamin E preparations or diabetes treatments within 24 weeks before the time of enrollment.
- •(12)Patients on insulin treatment or considered to be an absolute indication for insulin.
- •(13)Patients with active infections requiring systemic treatment.
- •(14)Patients with severe trauma.
- •(15)Patients with a history of surgery within the last 12 weeks from the time of enrollment.
- •(16)Patients with acute coronary syndrome, heart failure, stroke, or transient ischemic attack within 12 weeks before enrollment.
- •(17)Patients with a history of hypersensitivity to imeglimin hydrochloride components.
- •(18)Patients who are pregnant, breastfeeding, or may be pregnant.
- •(19)Patients unable to undergo MRI examination and those for whom it is contraindicated (pacemaker placement, claustrophobia, or difficulty holding breath, etc).
- •(20) Patients who are otherwise judged to be inappropriate for this study by the principal investigator or research co-investigator.
研究者
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