NCT00746486终止3 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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Rate of patients without treatment failure after 3 years of treatment
研究概览
简要总结
The study is aimed to compare the efficacy and tolerability of a combination therapy with ursodeoxycholic acid (12-16 mg/kg body weight (BW)/d) plus budesonide (9 mg/d) vs. ursodeoxycholic acid (12-16 mg/kg BW/d) plus placebo in the treatment of PBC. Depending on ALT values 6 mg/d budesonide are allowed. The study population will be patients with PBC at risk for disease progression. It is assumed that the combination therapy will result in a decrease of treatment failures after 3 years of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent
- •Age ≥ 18 years
- •UDCA treatment for at least 6 months prior to inclusion
- •Liver biopsy compatible with PBC
- •Liver biopsy performed within the last 6 months prior to inclusion
- •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
- •Type 2 anti-mitochondrial antibodies > 1:40 by direct immunofluorescence
- •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
排除标准
- •Histologically proven cirrhosis
- •Positive Hepatitis B or C serology
- •Positive HIV serology
- •Primary Sclerosing Cholangitis
- •Wilson's-Disease
- •Celiac Disease (blood tests and/or oesophago-gastro-duodenoscopy with histological examination to be performed)
- •α1-anti-Trypsin-deficiency
- •Haemochromatosis
- •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
- •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
- •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
- •Sonographic or endoscopic signs of portal hypertension
- •Ascites or history of ascites
- •Hepatic encephalopathy or history of hepatic encephalopathy
- •Total bilirubin > 3.0 mg/dl (> 50 µmol/L)
- •Albumin < 36 g/L
- •Prothrombin ratio < 70%
- •Platelet count < 135.000/mm3
- •Osteoporosis proven by bone densitometry
- •Diabetes mellitus, defined as B-Glucose > 125 mg/dl on an empty stomach (even when controlled)
- •Hypertension, defined as persistent raised blood pressure > 140/90 mmHg
- •Suspected non-compliance of the patient (suspected difficulties to comply with the study period of 36 months)
- •Severe co-morbidity substantially reducing life expectancy
- •Known intolerance/hypersensitivity/resistance to study drugs or drugs of similar chemical structure or pharmacological profile
- •Existing or intended pregnancy or breast-feeding
- •Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial
研究组 & 干预措施
A
Experimental
One budesonide 3 mg capsule TD or one budesonide 3 mg capsule BD and 12-16 mg ursodeoxycholic acid/kg BW/d
干预措施: budesonide (Drug)
B
Active Comparator
One placebo capsule TD or One placebo capsule BD and 12-16 mg ursodeoxycholic acid/kg BW/d
干预措施: budesonide placebo (Drug)
结局指标
主要结局
Rate of patients without treatment failure after 3 years of treatment
时间窗: 3 years, LOCF
次要结局
- course of pruritus(3 years, LOCF)
- course of fatigue(3 years, LOCF)
- course of Mayo Risk score(3 years, LOCF)
- bone mineral density(3 years, LOCF)
研究者
研究点 (2)
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