EUCTR2007-004040-70-AT进行中（未招募）不适用
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study comparing the combination of ursodeoxycholic acid capsules plus budesonide capsules to ursodeoxycholic acid capsules plus placebo in the treatment of primary biliary cirrhosis - Ursodeoxycholic acid plus budesonide vs. ursodeoxycholic acid alone in PBC
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 183
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
- •1. Signed informed consent
- •2. Age = 18 years
- •3. UDCA treatment for at least 6 months prior to inclusion
- •4. Liver biopsy compatible with PBC
- •5. Liver biopsy performed within the last 6 months prior to inclusion
- •6. PBC patients at risk of disease progression based on one or more of the following criteria:
- •- Serum alkaline phosphatase = 3 times the upper limit of normal at any time since diagnosis of PBC and ALT = 2 times upper limit of normal or
- •- Total Bilirubin = 1.0 mg/dl (= 17 µmol/L) or
- •- Moderate to severe periportal or periseptal lymphocytic interface hepatitis or- Periportal and portal fibrosis with numerous septa (Ludwig stage III) without cirrhosis
- •7. Type 2 anti-mitochondrial antibodies > 1:40 by direct immunofluorescence
- •8. Women of child-bearing potential have to apply appropriate contraceptive methods, e.g., hormonal contraception, intrauterine device (IUD), double-barrier method of contraception (e.g., use of a condom and spermicide), partner has undergone vasectomy and subject is in monogamous relationship. The investigator is responsible for determining whether the subject has adequate birth control for study participation
- •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
- •1. Histologically proven cirrhosis
- •2. Positive Hepatitis B or C serology
- •3. Positive HIV serology
- •4. Primary Sclerosing Cholangitis
- •5. Wilson’s-Disease
- •6. Celiac Disease (blood tests and/or oesophago-gastro-duodenoscopy with histological examination to be performed)
- •7. a1–anti-Trypsin-deficiency
- •8. Haemochromatosis
- •9. Autoimmune-Hepatitis (AIH; defined by an Alvarez score > 15 without treatment or = 17 with treatment); Note: PBC/AIH overlap disease, treated insufficiently with UDCA monotherapy may be enrolled
- •10. Treatment with any of the following drugs within the last 3 months prior to inclusion: colchicine, corticosteroids, azathioprine or other immunosuppressive drugs (e.g. cyclosporine, methotrexate), chlorambucil, D-penicillamine, fibrates, or antihyperlipidemic drugs
- •11. Treatment with ketoconazole or other CYP3A inhibitors within the last 4 weeks before baseline; rifampicin (up to 600 mg/d) is allowed to treat pruritus until baseline
- •12. Sonographic or endoscopic signs of portal hypertension
- •13. Ascites or history of ascites
- •14. Hepatic encephalopathy or history of hepatic encephalopathy
- •15. Total bilirubin > 3.0 mg/dl (> 50 µmol/L)
- •16. Albumin < 36 g/L
- •17. Prothrombin ratio < 70%
- •18. Platelet count < 135.000/mm3
- •19. Osteoporosis proven by bone densitometry
- •20. Diabetes mellitus, defined as B-Glucose > 125 mg/dl on an empty stomach (even when controlled)
- •21. Hypertension, defined as persistent raised blood pressure > 140/90 mmHg
- •22. Suspected non-compliance of the patient (suspected difficulties to comply with the study period of 36 months)
- •23. Severe co-morbidity substantially reducing life expectancy
- •24. Known intolerance/hypersensitivity/resistance to study drugs or drugs of similar chemical structure or pharmacological profile
- •25. Existing or intended pregnancy or breast-feeding
- •26. Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
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