EUCTR2014-002037-59-ES进行中（未招募）1 期
Clinical Study of the BreathID® LF System to train the algorithm for the ¹³C-Methacetin Breath Test (MBT) in assessment of Portal Hypertension in Patients with Compensated Liver Cirrhosis - Protocol Number: CSPH-EX-0414
Exalenz BioScience Ltd.0 个研究点目标入组 200 人开始时间: 2014年9月11日最近更新:
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
入选标准
- •1.Adult men or women (>18 years of age)
- •2.Able (or legal guardian) and willing to sign an Informed Consent Form
- •3.Known chronic liver disease with cirrhosis confirmed by either:
- •a.liver biopsy or
- •b.clinical (palpable left lobe, splenomegaly) and laboratory (platelets <150,000/mm3 or albumin< 3.8g/dL, or INR >1.3) evidence of cirrhosis and/or
- •c.imaging studies by abdominal sonography, computer assisted axial tomography, or magnetic resonance imaging, showing a nodular liver and/or enlarged spleen and/or portosystemic collaterals with portal vein patency and/or minimal ascites, and/or colloid shift on a colloid-isotope liver-spleen scan or measurements of liver stiffness suggestive of cirrhosis
- •4.Indicated to undergo HVPG testing
- •5.Can tolerate an overnight (8-hour) fast
- •6.For patients treated with beta blockers: They have to be on a stable dose for at least 6 weeks prior to any study related tasks (MBT or HVPG measurement)
- •7.For patients who stopped their treatment with beta blockers: Their last dose should be at least 6 weeks prior to any study related tasks (MBT or HVPG measurement)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •1.Decompensated cirrhosis as clinically defined by the occurrence of any of the following: ascites, hepatic encephalopathy, variceal bleeding or hepatorenal syndrome
- •2.Renal failure (creatinine > 2.5 mg/dl)
- •3.Known acute renal tubular disease
- •4.Known hypotension (Systolic Pressure <100mmHg)
- •5.Hypocoagulablity defined as PT >6 and INR >2.3.
- •6.Congestive heart failure (assessed clinically as NIHA >2)
- •7.Known pulmonary hypertension (right ventricular systolic pressure > 45 mm Hg)
- •8.Uncontrolled diabetes mellitus (HBA1C >9.5gr%)
- •9.Concurrent prednisone or immunosuppressive treatment, if therapy and/or response to treatment are not stable for at least 3 months.
- •10.Documented hepatocellular carcinoma lesion larger than 3cm and/or multifocal lesions and/or evidence of vascular invasions
- •11.Gastric bypass surgery or extensive small bowel resection
- •12.Total parenteral nutrition
- •13.Any organ transplant recipient
- •14.Pregnant or breast feeding
- •15.Allergy to acetaminophen and/or other related medications.
- •16.Documented drug-related concurrent hepatotoxicity or drug-related silent steatosis or drug-related fibrosis (e.g. amiodarone, methotrexate and tamoxifen)
- •17.Uncontrolled malabsorption or diarrhea
- •18.Documented non-cirrhotic PHT, partial / complete portal venous occlusion, hepatic venous occlusion, previous PHT surgery, or placement of a transjugular intrahepatic portosystemic shunt (TIPS)
- •19.Primary or secondary biliary cirrhosis, primary or secondary sclerosing cholangitis, hepatic sarcoidosis, or other cholestatic disorders
- •20.Subjects unable to perform the MBT within 7 days of HVPG procedure.
- •21.Subject should not have taken any of the following for 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
- •22.Subject should not have taken amiodarone or statins within the last 30 days prior to the breath test or HVPG procedure
研究者
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