EUCTR2007-004040-70-SE进行中（未招募）1 期
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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 144
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 start of baseline examinations
- •4. Liver biopsy compatible with PBC and assessed with inflammatoryactivity according to the mHAI score, Ishak et al.,
- •5. Liver biopsy performed within the last 6 months prior to start of baseline examinations
- •6. PBC patients with an incomplete response to UDCA treatment defined by the failure to achieve s-AP levels < 1.5x upper limit of normal after at least 6 months of treatment with UDCA and with inflammatory activity according to the mHAI sum score (Ishak et al., 1995) in the histological assessment of the liver
- •7. Type 2 anti-mitochondrial antibodies > 1:40 by indirect 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 114
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
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 (if not controlled)
- •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 corticosteroids (except inhalative corticosteroids) and immunosuppressants within the last 2 months prior to start of baseline examinations
- •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. Cataract
- •16. Albumin < 36 g/L
- •17. Prothrombin time < 70% , or if prothrombin time (%) not available, prothrombin ratio (INR) out of normal range and clinically significant
- •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 (i.e. having received the trial medication) in this trial
研究者
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