ISRCTN12358813进行中（未招募）3 期
Asp-PSC: effect of aspirin on reducing cancer & improving outcomes in primary sclerosing cholangitis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 968
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. Age 18 years or above
- •2. Able to give written and informed consent.
- •3. Must have an established clinical diagnosis of large duct PSC-based on a standard disease definition of typical cholangiography findings on endoscopic retrograde cholangiography (ERCP) or magnetic resonance cholangiography (MRCP).
- •4. An established diagnosis of concomitant colonic IBD either in a pattern of Ulcerative Colitis, Crohn’s disease or IBD unclassified.
- •5. Patients must be at least one-year post PSC diagnosis.
- •6. If pre-treated with ursodeoxycholic acid (UDCA) – UDCA therapy should remain at a stable dose for 12 weeks prior to screening, and not exceeding 20 mg/kg/day.
- •7. Must have had a colonoscopy within the last year of randomisation date as part of routine clinical care. If not this must be done within the screening interval.
- •8. If a patient has cirrhosis, they must have undertaken a hepatobiliary ultrasound (US), MRCP scan, magnetic resonance imaging (MRI) liver or regional computerised tomography (CT) scan within 6 months of screening date as part of routine clinical care. If not, this must be done within the screening interval.
- •9. If non-cirrhotic, then the patient must have had an US, MRCP, dynamic MRI or regional CT within the last 12 months as part of routine clinical care. If not, this must be done within the screening interval.
排除标准
- •1. Evidence of concomitant disease(s) that causes secondary sclerosing cholangitis
- •2. Evidence of any of the following diseases: IgG4 related disease, PBC, acute or chronic viral hepatitis, alcohol-related liver disease, Wilson disease, Budd-Chiari syndrome, portal vein thrombosis, alpha-1-antitrypsin disease, hepatic sarcoidosis, cystic fibrosis, Progressive familial intrahepatic cholestasis (PFIC), hereditary haemochromatosis, non-alcoholic steatohepatitis (NASH) – those with simple hepatic steatosis without evidence of NASH or liver fibrosis secondary to fatty liver disease are allowed to participate, other metabolic liver disease, active malignancy in the last 5 years (except treated/excised non-melanomatous skin cancer).
- •3. Have a previous diagnosis of colorectal cancer, cholangiocarcinoma, gallbladder cancer at any time point.
- •4. Has received a liver transplant, has been referred for liver transplant assessment, or is listed for a liver transplant.
- •5. Had any of the following procedures: colonic resection of any nature, including those with a defunctioning ostomy.
- •6. Consume more than the recommended allowance of 14 units of alcohol per week (as set out by the Department of Health).
- •7. Current or recent participation in any other clinical trial of an investigational medicinal product (CTIMP) within the last 6 weeks prior to first dose of aspirin/placebo
- •8. Already taking aspirin.
- •9. History of non-variceal upper gastrointestinal (GI) bleeding within 1 year.
- •10. A history of congestive cardiac failure.
- •11. A known diagnosis of glucose-6 -phosphate dehydrogenase.
- •12. Child Pugh B or C cirrhosis
- •13. Untreated thyrotoxicosis or hypothyroidism
- •14. Familial history of a hereditary cancer syndrome, or confirmed genetic predisposition that heightens cancer risk.
- •15. Vaccination for varicella zoster in the six weeks prior to screening period
- •16. Known allergy to aspirin
- •17. A history of NSAID/ aspirin induced asthma and nasal polyps
- •18. Concurrently taking non-steroidal anti-inflammatory drugs (NSAIDs) in the four weeks prior to screening
- •19. History of haemophilia and/or other bleeding disorders where aspirin is contraindicated
- •20. Taking other anti-platelet or anti-coagulant medication (e.g., clopidogrel, prasugrel, warfarin, apixaban, rivaroxaban, dabigatran or therapeutic heparin preparations)
- •21. Active, or history of recurrent peptic ulcer
- •22. Patients who are suffering from gout
- •23. Severe renal impairment
- •24. Taking methotrexate at a dose of >15mg/week
- •25. Taking selective serotonin-reuptake inhibitors
研究者
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