EUCTR2014-005411-16-ES进行中（未招募）1 期
Clinical Study of the BreathID® System to train the algorithm for the 13C-Octanoate Breath Test with or without the 13C-Methacetin Breath Test (OBT and MBT respectively) for correlation with histological findings of Non-Alcoholic Fatty Liver Disease (NAFLD). - NASH-EX-1114
Exalenz Bioscience Ltd.0 个研究点目标入组 200 人开始时间: 2015年8月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Adult men or women (?18 years of age)
- •2.Liver biopsy, indicated to rule-out or confirm NAFLD, performed within 6 months prior to both breath-tests
- •NOTE: The samples obtained must meet pre-defined quality criteria as an inclusion criterion.
- •3.No other known co-existent liver disease, excluded by appropriate serologic / other testing
- •4.Patient able and willing to sign an Informed Consent Form
- •5.Can tolerate an overnight (8-hour) fast
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Positive studies for any of the following within three years prior to biopsy:
- •*Anti HCV positive
- •*Anti HB core antibody positive
- •*Iron saturation > 60% + gene test for hereditary hemochromatosis or iron overload as defined by presence of 3+ or 4+ stainable iron on liver biopsy
- •*Antinuclear antibody at a titer > 1: 160 along with hypergammaglobulinemia and 5 times ALT normal levels
- •*Alpha-1-antitrypsin level below lower limit of normal (< 150 mg/dl) or no PAS diastase resistant globules on biopsy.
- •*Primary biliary cirrhosis as defined by elevation of alkaline phosphatase greater than upper limit of normal and anti-mitochondrial antibody (AMA) of greater than 1:80 and consistent liver histology
- •*Low level of ceruloplasmin
- •*Drug-induced liver disease as defined on the basis of typical exposure and history
- •2.Patients known to have chronic liver disease other than NAFLD as routinely diagnosed by the investigator
- •3.Concurrent acute hepatic condition other than NAFLD
- •4.Alcohol consumption > 20 gm/day (0.71 oz/day) for women and > 30 gm/day (1.06 oz/day) for men
- •5.Drugs that may interfere with octanoate metabolism or that can also cause NAFLD independent of the metabolic syndrome, including: corticosteroids, amiodarone, tetracycline, valproic acid, methotrexate, stavudine, zidovudine
- •6.When MBT is performed, subject should not have taken any of the following at least 48 hours prior to the breath test: Acyclovir , allopurinol, carbamazepine, cimetidine, ciprofloxacin, daidzein, (herbal) disulfiram, echinacea, enoxacin, famotidine, fluvoxamine, methoxsalen, mexiletine, montelukast, norfloxacin, phenylpropanolamine, phenytoin, propafenone, rifampin, terbinafine, ticlopidine, thiabendazole, verapamil, zileuton or oral contraceptives or any medication that might interfere with Methacetin metabolism or might affect CYP 1A2
- •7.Patients that have had more than 10% weight change between biopsy and enrollment.
- •8.Hypersensitivity to any of the study substrates: Octanoate or Methacetin and their metabolites, i.e. paracetamol, acetaminophen
- •9.Known extra-hepatic diseases including but not limited to: severe congestive heart failure (NIHA>2), known severe pulmonary hypertension (>35 mmHg), history of chronic obstructive pulmonary disease or uncontrolled symptomatic bronchial asthma or uncontrolled diabetes mellitus (HA1c>9.5%)
- •10.Previous surgical GI bypass surgery
- •11.Extensive small bowel resection (>100 cm)
- •12.Known uncontrolled malabsorption or diarrhea
- •13.Concurrent total parenteral nutrition
- •14.Any organ transplant
- •15.Patients receiving any anti-viral treatment or any other liver directed therapy, procedure or surgery between the time of the biopsy and the breath test
- •16.Pregnant or breast feeding
- •17.Patients unable or refusing to sign informed consent
- •18.Patients that, based on the opinion of the investigator, should not be enrolled into this study due to safety / adherence reasons.
- •19.Patients participating in other clinical trials and already receiving experimental treatments or procedures
- •20.Patients with suspected or documented hepatocellular carcinoma by ultra-sound or other imaging modality.
- •21.Patients diagnosed with partial / complete portal venous occlusion, hepatic venous occlusion, previous PHT surgery, or placement of a trans-jugular intrahepatic porto-systemic shunt (TIPS) according to initial imaging studies.
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