ISRCTN74815110已完成未知
Evaluating the benefits for patients and the UK National Health Service (NHS) of new and existing biological fluid markers in liver and renal disease: a prospective multicentre randomised trial
niversity of Leeds (UK)0 个研究点目标入组 878 人开始时间: 2009年11月11日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 878
研究概览
简要总结
2018 results in https://pubmed.ncbi.nlm.nih.gov/29995365/ (added 29/12/2020)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Registration:
- •1. Patients with chronic liver disease and pre-cirrhotic moderate to severe fibrosis as classified by clinical, laboratory, or histological evidence, due to viral hepatitis B or C, non-alcoholic fatty liver disease, alcoholic liver disease, primary biliary cirrhosis (PBC), primary sclerosing cholangitis (PSC), autoimmune hepatitis (AIH), haemochromatosis, or combinations of these diseases
- •2. Clinical evidence of chronic liver disease as evidenced by documented abnormalities of liver function for more than six months including:
- •2.1. Elevated liver enzymes (alanine aminotransferase [ALT], asparate aminotransferase [AST], gamma glutamyl-transferase [GGT])
- •2.2. Elevated bilirubin with raised liver enzymes
- •2.3. Symptoms or signs of chronic liver disease (including jaundice, clubbing, palmar erythema, spider naevae)
- •3. Chronic liver disease due to:
- •3.1. Virus-serological and nucleic acid evidence of chronic Hepatitis C, chronic Hepatitis B
- •3.2. Fat: ultrasound evidence of fatty liver disease
- •3.3. Alcohol: history of excessive alcohol consumption
- •3.4. Autoimmune hepatitis (smooth muscle antibodies [SMA], anti-nucleur antibodies [ANA], liver-kidney-microsome antibodies [LKMA] and raised immunoglobins)
- •3.5. Primary biliary cirrhosis (anti-mitochondrial antibodies [AMA], M2 antibodies)
- •3.6. Primary sclerosing cholangitis (endoscopic retrograde cholangiopancreatography [ERCP] or magnetic resonance cholangiopancreatography [MRCP] evidence of beading of biliary tree)
- •3.7. Haemochromatosis-HFE genotype HDCY or HHYY with liver biopsy evidence of iron overload
- •4. Aged greater than or equal to 18 years old and less than 75 years of age, either sex
- •5. Give their written, informed consent to participate
- •6. Likelihood of ability to comply with the follow-up schedule
- •7. Life expectancy greater than 6 months
- •Randomisation:
- •8. An ELF score of greater than or equal to 10.5
排除标准
- •Registration:
- •1. Unable to provide consent
- •2. Clinical, histological or laboratory diagnosis of cirrhosis (other than ELF) such as hepatic impairment as evidenced by any one of the following:
- •2.1. Platelets less than the lower limit of normal (LLN)
- •2.2. Albumin less than LLN
- •2.3. Ultrasound of other imaging evidence of cirrhosis (coarse echo texture, irregular outline to liver, splenomegally)
- •3. Any episode of hepatic decompensation compatible with cirrhosis including:
- •3.1. Encephalopathy, variceal bleeding, ascites
- •3.2. Established diagnosis of hepatocellular cancer
- •3.3. Elevated alpha feto-protein without investigation to exclude HCC
- •4. Previously screened and found ineligible for the ELUCIDATE Trial
- •Note that human immunodeficiency virus (HIV) co-infection is NOT an exclusion criterion.
- •Randomisation:
- •5. An ELF score of less than 10.5
研究者
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