ISRCTN17176388进行中（未招募）Unknown
Optimising primary therapy in primary biliary cholangitis
ewcastle upon Tyne Hospitals NHS Foundation Trust0 个研究点目标入组 106 人开始时间: 2023年7月10日最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
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. Established diagnosis of PBC based on the presence of at least 2 out of the 3 key disease characteristics, specifically:
- •1.1.AMA or PBC-specific ANA at a clinically diagnostic level
- •1.2.Elevated alkaline phosphatase (above the upper limit of normal (ULN) for the relevant laboratory)
- •1.3.Compatible or diagnostic liver biopsy
- •2. Ongoing elevation of alkaline phosphatase (=15% above ULN) at screening
- •3. Disease duration of <6 months from date of diagnosis at the time of consent
- •4. Use of UDCA for <3 months at the time of consent
- •5. Pre-treatment Ursodeoxycholic Acid Response Score with a predicted risk of future non-remission of liver biochemistry (ie ALP>ULN) with UDCA alone of >20%
- •6. For people of childbearing potential: an agreement to use at least an acceptable effective method contraception or to practise sexual abstinence to avoid pregnancy for entire duration of the study period.
- •7. Willing to complete the study assessment protocols
- •8. Ability to consent, able to comply with study protocol and attend clinic visits
- •9. Age = 18 years at the time of consent
排除标准
- •1. Clinical contraindication to obeticholic acid use
- •2. Untreated, clinically significant pruritus (patients with effectively treated pruritus are eligible for inclusion)
- •3. Concomitant use of fibric acid derivatives (e.g. bezafibrate or fenofibrate) within 14 days prior to screening
- •4. Clinical suspicion of cirrhosis evidenced by a history of one or more of the following:
- •4.1. ascites requiring diuretic therapy or percutaneous drainage
- •4.2. endoscopically-confirmed varices
- •4.3. liver biopsy suggesting cirrhosis
- •4.4. platelet count <150 x109/L
- •4.5. transient elastography score >16.9 kPa within 3 months prior to or at screening
- •4.6. hepatocellular carcinoma confirmed by biopsy or 2 imaging modalities
- •4.7. hepatic encephalopathy
- •5. Bilirubin >twice the upper limit of normal
- •6. Evidence of complete biliary obstruction
- •7. Previous exposure to obeticholic acid (either in clinical trials or in clinical practice) or other potential PBC-modifying therapy
- •8. Regular (more than one week per month) alcohol consumption in excess of recommended safe limits (14 units per week)
- •9. Active participation in another interventional trial or exposure to another experimental drug within 5 half-lives
- •10. Pregnancy or planning to get pregnant within duration of participation in the trial
- •11. Currently breastfeeding
- •12. Overlapping features of an additional liver disease, including autoimmune hepatitis (using the Paris criteria for autoimmune hepatitis overlap)
- •13. Hypersensitivity to the active substance or to any of the excipients
- •14. If the participant’s treating clinician deems the patient is not suitable to participate in the trial based on other criteria apparent during screening or from medical history
- •15. Previous liver transplantation
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