EUCTR2011-002754-31-DK进行中（未招募）不适用
Double-blind, randomized, placebo-controlled, phase II dose-finding study comparing different doses of norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis - Norursodeoxycholic acid vs. Placebo in PSC
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 160
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.Male or female patients = 18 and < 80 years,
- •4.Alkaline Phosphatase = 1.5 x ULN at baseline,
- •6.Women of child-bearing potential have to apply during the entire duration of the study a highly effective method of birth control, which is defined as one which results in a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method, or some IUDs. Women of non-childbearing potential may be included if surgically sterile or post-menopausal for at least 2 years. The investigator is responsible for determining whether the subject has this 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 120
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •1.History or presence of other concomitant liver diseases including:
- •Positive hepatitis B or C serology (Hbs Ag+, anti-HBc+, anti-HCV;
- •Note: Patients who present with anti-HBc+ only, may be included if they are HBV-DNA negative)
- •Primary Biliary Cirrhosis, (AMA-positive)
- •Wilson’s Disease
- •Haemochromatosis
- •Autoimmune Hepatitis
- •Chronic alcoholic consumption (daily consumption >30g/d)
- •Biopsy proven NASH
- •Cholangiocarcinoma,
- •2.Treatment with any of the following drugs within the last 3 months prior to baseline: any glucocorticosteroids (including budesonide), azathioprine or other immunosuppressive drugs (e.g. cyclophosphamide, cyclosporine, methotrexate, tacrolimus, 6-mercaptopurine), chlorambucil, pentoxyfylline, penicillamine, pirfenidone, fibrates, biologics (e.g., anti-tumor necrosis factor-alpha therapy), or rifampicin,
- •5.Child B/C liver cirrhosis,
- •12.Total bilirubin > 3.0 mg/dl (> 51.3 µmol/L), at screening or baseline,
- •13.Both total bilirubin levels > ULN within the last 6 months prior to baseline and a rise of this level by more than 50% within the last 6 months prior to baseline,
- •14.Albumin < 36 g/L, at screening or baseline,
- •16.Any relevant systemic disease (e.g., AIDS),
- •17.Abnormal renal function (Cystatin C >1,15 X ULN) at screening and/or at baseline visit,
- •18.TSH > ULN at screening,
- •20.Any active malignant disease,
- •21.Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile
研究者
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