EUCTR2009-011926-32-GB进行中（未招募）不适用
Breath Test for Patients with Acute Liver Disease for early Detection of the Need for Transplant or Recovery - Breath Test for Patients with Acute Liver Disease
Exalenz Bioscience Ltd0 个研究点目标入组 112 人开始时间: 2009年8月7日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 112
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
- •Inclusion Criteria
- •1.Adult men or women (>18 years of age).
- •2.Acute Liver insult
- •3.No evidence of cirrhosis (unless clinical acute Wilsons)
- •4.INR > 1.8
- •5.Duration of illness < 12 and 24 weeks
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion Criteria
- •1.Patient with any chronic liver disease
- •2.Patient has severe congestive heart failure
- •3.Patient has severe pulmonary hypertension
- •4.Patient has chronic renal insufficiency with severe cardiac disease
- •5.Patient has previous surgical bypass surgery for morbid obesity
- •6.Patient has extensive small bowel resection
- •7.Patient with any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication
- •8.Patient is a recipient of any organ transplant
- •9.Patient with proven or suspected hepatocellular carcinoma
- •10.Patient is pregnant
- •11.Patient allergic to acetaminophen (such as Tylenol or any other related medications)
- •12.Patient with history of chronic obstructive pulmonary disease or symptomatic bronchial asthma
- •13.Patients with septic cholestasis
- •14. Patients currently receiving total parenteral nutrition if they have contraindications to oral drugs
- •15.Patients that are taking hepatotoxin drugs
- •16.Patient, based on the opinion of the investigator, should not be enrolled into this study
- •17.Patients unable or unwilling to sign informed consent
- •18.Patients that are participating in other clinical trials evaluating experimental treatments or procedures
- •Exclusion Criteria (Day of MBT)
- •1.Patient has not fasted for 8 hours
- •2.Patient has smoked on the day of the test
- •3.Patient that has taken drugs that can interfere with methacetin metabolism : fluvoxamine, amiodarone, ciprofloxacin, cimetidine, rifampin, carbamazepine within the last 24 hours
- •4.Patient has taken Tylenol or any other acetaminophen related medications within the past 24 hours
- •5.Patients that received general anesthesia or conscious sedation in the last 24 hours
- •6.Patient has consumed alcohol within the past 24 hours
- •7.Patients that still suffer from any previous clinical intervention (e.g. biopsy)
研究者
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