EUCTR2007-004040-70-GB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
相关药物
试验速览
- 阶段
- 1 期
- 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:
- •-PBC patients at risk of disease progression based on one or more of the
- •following criteria:
- •- Serum alkaline phosphatase = 3 times upper limit of normal (corresponding to 312 U/L for women and 387 U/L for men) at any time since diagnosis of PBC or
- •- ALT or AST = 2 times upper limit of normal (corresponding to 70 U/L for women and100 U/L for men) at inclusion 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 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
- •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 (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) within the last 2 months prior to inclusion and/or treatment with any of the following drugs within the last 3 months prior to inclusion: colchicine, 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 time < 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
研究者
相似试验
进行中（未招募）
1 期
Double-blinded, randomised, placebo-controlled, multicentre , Phase IIa study to investigate the effect efficacy, safety and tolerability of phosphorylcholine human monoclonal antibody (PC-mAb) 3G10 on arterial inflammation, together with safety and tolerability, in subjects with elevated lipoprotein a (Lp[a ])Arterial inflammation in subjects with elevated lipoprotein a (Lp[a])MedDRA version: 20.0Level: LLTClassification code 10051615Term: Atherosclerotic cardiovascular diseaseSystem Organ Class: 100000022953EUCTR2017-002106-13-SEAthera Biotechnologies AB40
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 PBCPatients with Primary Biliary Cirrhosis at risk of disease progressionMedDRA version: 9.1Level: LLTClassification code 10036680Term: Primary biliary cirrhosisEUCTR2007-004040-70-ATDr. Falk Pharma GmbH183
进行中（未招募）
不适用
Double-blind, randomised, placebo-controlled, multi-centre phase III clinical study on the efficacy and tolerability of budesonide capsules versus placebo for maintenance of remission in patients with collagenous colitis - SOIBD Collagenous Colitis Maintenance Study (SCCMS)EUCTR2007-001315-31-CZDr. Falk Pharma GmbH110
进行中（未招募）
1 期
Study to compare the combination of ursodeoxycholic acid andbudesonide with the combination of ursodeoxycholic acid and placebo inthe treatment of primary biliary cirrhosisPBC 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 in the histological assessment of the liverMedDRA version: 17.0Level: LLTClassification code 10036680Term: Primary biliary cirrhosisSystem Organ Class: 100000004871EUCTR2007-004040-70-SEDr. Falk Pharma GmbH144
进行中（未招募）
不适用
Study to evaluate the effectiveness and safety of 3 doses ofembryonated eggs of the porcine whipworm compared to placebo(dummy drug) in the treatment of active Crohn's disease.EUCTR2006-000720-13-CZDr. Falk Pharma GmbH400