CTRI/2022/03/041481进行中（未招募）3 期
A Prospective, Randomized, Double-Blind, Two-arm, Placebo-Controlled Comparative Clinical Study To Evaluate The Efficacy And Safety of Liv.52 DS tablets in Metabolic dysfunction-Associated Fatty Liver Disease (MAFLD): An Exploratory Study. - MAFLD
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
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
- •Adult male and female subjects aged between =18 and =65 years.
- •Subjects who are clinically diagnosed with Metabolic dysfunction-associated Fatty Liver Disease (MAFLD) defined as Hepatic Steatosis in adults (detected either by imaging techniques, blood biomarkers/scores or by liver histology) in addition to one of the following criterias, namely,
- •A. Overweight or obesity (defined as BMI =25 kg/m2 in Caucasians or BMI =23 kg/m2 in Asians)
- •B. Type 2 Diabetes Mellitus C. Lean or normal weight (defined as BMI <25 kg/m2 in Caucasians or BMI <23 kg/m2 in Asians) with the presence of at least 2 metabolic risk abnormalities from the listed below,
- •Waist circumference =102/88 cm in Caucasian men and women or =90/80 cm in Asian men and women
- •Blood pressure =130/85 mmHg or specific drug treatment
- •Plasma triglycerides =150 mg/dl (=1.70 mmol/L) or specific drug treatment Plasma HDL-cholesterol <40 mg/dl ( <1.0 mmol/L) for men and <50 mg/dl ( <1.3 mmol/L) for Women or specific drug treatment o Prediabetes (i.e., fasting glucose levels 100 to 125 mg/dl [5.6 to 6.9 mmol/L], or 2-hour post-load Glucose levels 140 to 199 mg/dl [7.8 to 11.0 mmol] or HbA1c 5.7% to 6.4% [39 to 47 mmol/mol])
- •Homeostasis model assessment of insulin resistance score =2.5 o Plasma high-sensitivity C-reactive protein level >2 mg/L 3. Non-invasive FIBROSCAN confirmed hepatic steatosis and stiffness as defined by,
- •Liver Stiffness Measurement score of =6.2 to = 9.8 Kpa from Vibration Controlled Transient Elastography (VCTE)
- •Any grade of steatosis (S1-S3) from Continuous Attenuation Parameter (CAP)
- •AST value of >1.5 times the Upper Limit of the Normal.
- •ALT = 1.5 times the Upper Limit of the Normal. 5. Female must be either of non-child bearing potential (surgically sterilized at least 6 months prior to screening or postmenopausal) or using one or more methods of contraception and non-lactating.
- •Subjects willing to sign informed consent.
排除标准
- •FIBROSCAN confirmed LSM score > 9.8kpa (F3-F4) confirmed through VCTE.
- •History of histologic confirmed MAFLD with advanced fibrosis (stage 3, 4).
- •History of Cirrhosis or its complications(like HCC, Portal HTN, Liver failure).
- •Complications may involve:
- •Patients listed for living-related or orthotopic liver transplantation
- •Patients with a history of hepatocellular carcinoma (HCC) or history of HCC treatment.
- •Evidence of portal hypertension (e.g., low Platelet counts,
- •esophageal varices, ascites, history of hepatic encephalopathy, splenomegaly)
- •(Radiologic imaging consistent with cirrhosis or portal hypertension would also be excluded)
- •Other cause of Steatosis (Hep-C, Wilson Disease, Medications, Severe malnutrition).
- •Subjects diagnosed as Alcoholic Liver Disease (ALD) ? on the basis of all of the following criteria:
- •Patient with a history of alcohol abuse based on AUDIT questionnaire (A total sum of >8 for men and >4 for women)
- •Active alcohol use until 4 weeks prior to screening
- •Patients with elevated liver function test of ALT and AST >1.5 times of upper limit of normal.
- •Ultrasound evidence Alcoholic fatty liver and / or Alcoholic Hepatitis Alcohol Liver disease.
- •Maddrey Discriminant function (DF) less than 32.
- •History of other co-existing Chronic Liver Diseases (such as Chronic Viral hepatitis, Hemochromatosis, Autoimmune Liver Disease, DILI, Alpha-1 Anti-trypsin Deficiency etc).
- •Subjects with history of myopathies or evidence of active muscle diseases.
- •Evidence of poorly-controlled diabetes [glycosylated haemoglobin (HbA1c) > 9%].
- •Subject with the history of type I diabetes mellitus.
- •Other Laboratory Screening Results:
- •Total white blood cells (WBC) <3,000 cells/mm3
- •Absolute neutrophil count (ANC) <1,500 cells/mm3
- •Platelet count <1,00,000/mm3
- •Prothrombin time > 1.2 INR
- •Creatine kinase above the upper limit of normal (ULN) except when in relation with intense exercise.
- •Serum creatinine >2 mg/dL or creatinine clearance <60 ml/min (based on MDRD)
- •Subject on fibrates (Other drugs for dyslipidaemia will be allowed provided dose is stable in last 6 months).
- •Use of drugs associated with a clinical or histological picture consistent with fatty liver disease or MAFLD for more than12 consecutive weeks in the 1 year prior to start of the study; (these include amiodarone, tamoxifen, methotrexate, glucocorticoids, anabolic steroids, tetracyclines, estrogens, valproate/valproic acid, chloroquine, anti-HIV drugs etc.).
- •Subjects with uncontrolled clinically significant serious conditions like severe anemia, severe cardiovascular disease, respiratory, hepatic, neurological, psychiatric, or malignancy/bleeding disorder or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this
- •study, or will make implementation of the protocol or interpretation of the study results difficult.
- •History of bariatric surgery within 1 year or planned Bariatric surgery.
- •Known history of drug abuse/dependency that would limit ability to comprehend or follow instructions related to informed consent, treatment instructions, study procedures or follow-up guidelines.
- •Known allergy, sensitivity or intolerance to the study drugs or their
研究者
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