2023-504100-28-00招募中2 期
Randomized, double-blind, placebo-controlled study on the efficacy and safety of nicotinamide in patients with liver fibrosis.
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年6月5日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in liver stiffness measured by Fibroscan® at 12 months after the start of treatment compared to baseline.
研究概览
简要总结
To determine the efficacy of NAM administration (1.2 g/m², up to a maximum of 3 g/day) on the development and progression of liver fibrosis, monitored through the use of FibroScan® along with the Enhanced Liver Fibrosis (ELF™) test over a 12-month period in overweight subjects with NAFLD (FibroScan® with CAP >250 dB/m) and early-stage liver fibrosis (FibroScan® >8 kPa).
研究设计
- 分配方式
- Randomized
- 主要目的
- Nicofib
- 盲法
- Double (Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 85 years.
- •Diagnosis of NASH by their referring physicians (NASH defined as presence of hepatic steatosis and in the absence of significant alcohol consumption and having excluded other liver diseases).
- •BMI between 27-40 kg/m
- •Fibroscan® value higher than 8kPa.
- •ELF test > 7.7
排除标准
- •Patients with any medical condition or disease that, in the opinion of the investigator, could interfere with the results of the study and/or affect the patients' ability to participate in or complete the study.
- •Patients with hypersensitivity or a history of severe allergies to NAM or excipients used in the preparation of the capsules (NAM and placebohard gelatin, microcrystalline cellulose, and colloidal silica).
- •History or evidence of an autoimmune disorder considered clinically significant by the investigator or requiring systemic, chronic use of systemic corticosteroids or other immunosuppressants.
- •Patients being treated with hepatotoxic drugs (amiodarone, immunosuppressants, ART, anti-tuberculosis drugs, corticosteroids, etc.).
- •Patients who consume narcotic and psychotropic substances with hepatotoxic effects.
- •Individuals with disabling illnesses or cognitive impairment.
- •Institutionalized patients or patients without a fixed address.
- •Principal investigator judgment in case there are indications of low adherence to the trial or follow-up visits.
- •People with a life expectancy of less than 12 months.
- •Patients participating in another interventional clinical trial, excluding observational/natural history studies, at baseline or within the last 30 days before the start of the study.
- •Previous use of vitamin B3 (NAM), abstinence must be at least 3 months before screening.
- •History of clinically significant heart disease (ejection fraction <40% [normal range 50-70%], heart failure defined as New York Heart Association [NYHA] Class > 2; clinically significant congenital or acquired valvular disease; symptomatic coronary artery disease such as myocardial infarction or angina pectoris, history of unstable arrhythmias, history of atrial fibrillation).
- •Pregnant women as determined by a positive high-sensitivity serum or urine pregnancy test (minimum sensitivity of 25 IU/L or hCG equivalent units) within 24 hours prior to screening, or dosing or completion of the study. Participating women of childbearing potential (WOCBP) will have a pregnancy test (serum or urine) performed 24 hours prior to screening, dosing, or completion of the study. These participants must use a highly effective contraceptive method such as combined hormonal contraceptives or intrauterine device (IUD), according to the Clinical Trial Facilitation Group, throughout the entire study.
- •Breastfeeding women.
- •Patients who are receiving treatment/supplementation with vitamin E.
- •Patients receiving probiotics.
- •Patients on the waiting list to undergo bariatric surgery in the next 12 months.
- •Patients undergoing treatment with drugs that may have an effect on the progression of liver disease.
- •Drugs for the treatment of T2DM with effects on NAFLD (GLP1 analogues, thiazolidinediones, such as pioglitazone) started within 6 months before the start of the study.
- •Drugs for the treatment of T2DM with effects on the intestinal microbiota (metformin, α-GI inhibitors, DPP-4 and SGLT-2 inhibitors) initiated within 6 months before the start of the study
- •Patients who do not sign the informed consent.
- •Decreased renal function (estimated glomerular filtration rate <45 ml/min/1.73 m2, calculated using the CKD-EPI formula) at screening.
- •Alcohol consumption greater than 30 g/day in men or 20 g/day in women.
- •Patients with significant alteration of liver function in the screening workup defined as repeated values of AST, ALT, and bilirubin > 3 times the upper limit of normal.
- •Positive for hepatitis B surface antigen or hepatitis C antibodies. Patients with hepatocarcinoma. Patients with liver cirrhosis (Fibroscan® > 18, compatible biopsy or who have suffered decompensation of cirrhosis). Patients diagnosed with human immunodeficiency virus (HIV). Patients with hypersensitivity or history of severe allergy to NAM or excipients used in the preparation of the capsules (NAM and placebo). History or evidence of an autoimmune disorder considered clinically significant by the investigator or requiring systemic, chronic use of systemic corticosteroids or other immunosuppressants.
- •Patients under treatment with hepatotoxic drugs (amiodarone, immunosuppressants, ART, antituberculosis drugs, corticosteroids, etc). Patients consuming narcotic and psychotropic substances with hepatotoxic effects. Individuals with incapacitating diseases or cognitive impairment. Institutionalized patients or patients with no fixed abode. Principal investigator criteria in the case of indications of low adherence to the trial or follow-up visits. People with a life expectancy of less than 12 months. Patients participating in another interventional clinical trial, excluding observational/natural history studies, at baseline or in the last 30 days before the start of the study. Prior use of vitamin B3 (NAM), abstinence must be at least 3 months prior to screening.
- •Pregnant women as determined by a positive hCG test (serum or urine) at screening or prior to dosing. Participants of childbearing age should use adequate contraception. Nursing women.
- •Patients undergoing treatment/supplementation with vitamin E. Patients on the waiting list for bariatric surgery in the next 12 months. Patients undergoing treatment with drugs that may have an effect on the evolution of liver disease.
结局指标
主要结局
Changes in liver stiffness measured by Fibroscan® at 12 months after the start of treatment compared to baseline.
Changes in liver stiffness measured by Fibroscan® at 12 months after the start of treatment compared to baseline.
Changes in the quantification of intrahepatic fat measured by CAP at 12 months after the start of treatment compared to the initial value.
Changes in the quantification of intrahepatic fat measured by CAP at 12 months after the start of treatment compared to the initial value.
Changes in the value obtained through the ELFTM Test (metabolomics-based methodology) at 12 months after the start of treatment compared to the initial value.
Changes in the value obtained through the ELFTM Test (metabolomics-based methodology) at 12 months after the start of treatment compared to the initial value.
Histological changes in case of final liver biopsy in patients with a biopsy prior to the start of the study.
Histological changes in case of final liver biopsy in patients with a biopsy prior to the start of the study.
次要结局
- Changes in the distribution of body adiposity, measured by bioimpedance at 12 months after the start of treatment with respect to the initial value.
- Cambios en la composición relativa de la microbiota intestinal analizada en heces mediante metabolómica y de las concentraciones séricas de metabolitos relacionados con su metabolismo, a lo largo del tratamiento (basal, 3, 6, y 12 meses).
- Changes in circulating levels of cytokines/adipokines related to systemic inflammation throughout treatment (baseline, 3, 6, and 12 months). This point will be assessed at the end of the study, by means of a sample from the biobank.
研究者
UICEC
Scientific
Fundacio Institut De Recerca De L Hospital De La Santa Creu I Sant Pau
研究点 (2)
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