CTRI/2022/04/041926已完成2 期
A Randomized, Multicenter, Double-blinded, Parallel-group, Phase 2 Study to Evaluate Efficacy and Safety of Livitol among Patients with Moderate to Severe Non-alcoholic fatty liver [steatosis].
Dr Reddys Laboratories0 个研究点目标入组 76 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
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
入选标准
- •1. Age 18-65 years at study entry.
- •2. Male, or female diagnosed with non-alcoholic fatty liver (steatosis), but if female, meets all the following criteria:
- •a. Not breastfeeding
- •b. Post-menopausal or negative urine pregnancy test result at Screening /Visit 1 (not required for hysterectomized females).
- •c. If of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year, when used consistently and correctly, such as double barrier methods [male condom with spermicide, with or without cervical cap or diaphragm], implants, injectables, oral contraceptives [must have been using for at least the last
- •3 months], some intrauterine contraceptive devices, tubal ligation, or in an established relationship with a vasectomized partner) during the entire duration of the study.
- •3. Patients diagnosed with moderate to severe fatty liver based on ultrasound (if ultrasound is available within 3 months of screening, it would be considered valid for screening).
- •4. Patients with liver fat greater than 15% as measured by MRI-PDFF at Screening.
- •5. Can read, understand, and sign the informed consent form (ICF) and communicate with the investigator, and understand and comply with protocol requirements.
排除标准
- •1. eGFR less than 60ml/min/1.73m2 at screening (chronic kidney disease epidemiology collaboration [CKD-EPI] formula).
- •2. Elevation of AST or ALT greater than five times upper limit normal (ULN).
- •3. Evidence of significant alcohol consumption (defined as more than 7 drinks/week for females and greater than 14 drinks/week for males) within 6 months prior to randomization
- •4. Body Mass Index (BMI) more than or equal to 40 kg/m2
- •5. Use of any of the following medications in the last 12 weeks prior to screening visit:
- •a. Metformin greater than 2 g/day
- •b. Insulins – all forms
- •c. Use of sildenafil, tadalafil, vardenafil, pioglitazone, rosiglitazone, alpha blockers, oral nitrates.
- •d. Medications associated with increased hepatic steatosis.
- •Commonly used medications associated with drug induced hepatic steatosis include amiodarone, valproate, tamoxifen, methotrexate, and some chemotherapeutic and antiretroviral agents, and steroids.
- •e. Organic Cation Transporter 2/MATE inhibitors (Includes
- •multidrug and toxin extrusion protein 1 and multidrug and toxin
- •extrusion protein 2 inhibitors like:
- •i. Methotrexate
- •ii. Tamoxifen
- •f. Corticosteroids (Nasal steroids are allowed if the subject has been on a stable dose for the past 12 weeks and the dose employed does not exceed the maximal recommended dose)
- •g. Estrogens
- •h. Amiodarone
- •i. Valproic acid
- •j. Coumadin
- •k. Isoniazide
- •l. Nucleoside analogues used for the treatment of human
- •immunodeficiency virus (HIV) infections
- •m. Any dietary supplement including Vitamin E and L-Carnitine other than multi-vitamins.
- •6. Presence or suspicion of other forms of chronic liver disease (e.g., cirrhosis, autoimmune hepatitis (greater than 1 is to 160 Anti-Nuclear Antibody ANA), Wilsons disease, Hemochromatosis (Ferritin greater than 1000 ug/L and percent iron saturation
- •greater than 45 percent), hepatitis A, B or C), primary biliary cholangitis, primary sclerosing cholangitis, Wilsons disease, homozygous alpha 1 anti trypsin deficiency.
- •7. Has a clinically significant medical condition that could potentially affect study participation and/or personal well-being, as judged by the investigator, including but not limited to the following conditions:
- •a. Unable to undergo MRI or contraindications for MRI procedure
- •b. History of cardio or cerebro vascular disease event within the previous 6 months
- •c. Requires anti coagulation therapy
- •d. Gastrointestinal disorders including, but not limited to, the following:
- •pancreatitis, inflammatory bowel disease, or other diseases associated with malabsorption or persistent abdominal discomfort
- •e. Endocrine disorders, other than type 2 diabetes and hypothyroidism on stable replacement therapy for 3 months prior to enrolment.
- •f. Chronic infection (e.g., tuberculosis, HIV infection, hepatitis A virus, hepatitis B virus, or hepatitis C virus)
- •g. Neurological or psychiatric diseases that preclude valid execution of informed consent or may interfere with the subjects compliance with study procedures (e.g., major depressive disorder within the last 2 years, a history of suicidal behaviour in the last 3 months). This will be based on investigator’s opinion and does not need formal psychological screening.
- •h. History of other psychiatric disorders including schizo
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