ISRCTN63745312已完成未知
A controlled trial of Orlistat (Xenical) for patients with non-alcoholic steatohepatitis (NASH)
The Newcastle upon Tyne Hospitals NHS Trust (UK)0 个研究点目标入组 50 人开始时间: 2005年10月27日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- 性别
- All
入选标准
- •1. Adult more than 18 but less than 75 years
- •Children will not be included in this study for three reasons:
- •1.1. The development of NASH in children may be due to different age-related metabolic processes than in adults
- •1.2. Children with NASH are always obese and their elevated aminotransferases normalise with weight loss or vitamin E treatment
- •1.3. The natural history of NASH in children is unknown and may not be sufficient to warrant the risk of using a new class of drug and performing a follow up liver biopsy. Orlistat is not approved for use in children
- •2. Body mass index (BMI) more than 28 kg/m^2. Orlistat is only licensed for patients with this degree of obesity
- •3. Liver biopsy obtained no more than six months before randomisation with a pathology report confirming that the histological diagnosis is consistent with NASH. A longer time period would increase the chances that the liver pathology had altered since the original biopsy
- •4. No more than 5% weight loss since liver biopsy. More weight loss would increase the chances that the liver pathology had altered since the original biopsy
- •5. Raised alanine transaminase (ALT) and/or aspartate transaminase (AST) and/or gamma-glutamyltransferase (GGT). This allows assessment of whether treatment improves liver blood tests
- •6. Ability to give informed consent
- •7. A satisfactory blood count, renal function and albumin. Ensures second biopsy likely to be safe (blood count, renal function) and that liver disease is not too far advanced (albumin)
排除标准
- •1. Evidence of decompensated liver disease such as a history of or presence of ascites, bleeding varices, or spontaneous encephalopathy. These patients are considered too advanced to benefit from treatment
- •2. Any cause for chronic liver disease other than NASH
- •3. Alcohol consumption greater than ?sensible? alcohol limits ? three units (~8-10 g) per day for males and two units per day for females during the past five years
- •4. Markers of active hepatitis virus infection (hepatitis B surface antigen [HBsAg], hepatitis C virus antibody [HCV Ab])
- •5. Patients on medications known to be associated with NASH
- •6. Total parenteral nutrition (TPN) within the past six months
- •7. Prior obesity surgery including gastric or intestinal bypass procedures
- •8. Evidence of genetic haemochromatosis - patients with raised ferritin or
- •transferrin and either homozygous for the C282Y HFE mutation or compound C282Y/H63D heterozygotes to be excluded. All these groups of patients are considered to have alternative causes for their liver disease or 'secondary' rather than true 'primary' NASH.
- •9. Type one diabetes or type two diabetes mellitus on any form of treatment (either insulin or oral hypoglycaemic)
- •10. Previous therapy for NASH including ursodeoxycholic acid, metformin, glitazones
- •11. Current treatment with fibrates. These treatments may be of benefit in NASH and would therefore confound any effects of Orlistat
- •12. History of prior organ transplantation. Immunosuppression and risk of recurrent disease (in liver transplant recipients) likely to confound any effects of Orlistat
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