EUCTR2021-001431-56-DE进行中（未招募）1 期
Double-blind, randomised, placebo-controlled, phase II dose-finding study comparing different doses of norucholic acid tablets with placebo in the treatment of primary biliary cholangitis in patients with an inadequate response to ursodeoxycholic acid - NCA vs. placebo in PBC
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •Signed informed consent,
- •Male or female patients = 18 and = 74 years at screening,
- •PBC verified by at least 2 out of the following 3 criteria at screening:
- •- Chronic cholestatic disease of at least 12 months duration,
- •- Positive anti-mitochondrial antibody (AMA) titer or, if AMA negative or in low titer (< 1:80), presence of PBC-specific antibodies (anti-GP210 and/or
- •anti-SP100 and/or antibodies against the major M2 components [PDC-E2, 2-oxo-glutaric acid dehydrogenase complex]),
- •- Liver biopsy available for review and compatible with the diagnosis of non-cirrhotic PBC,
- •Ursodeoxycholic acid (UDCA) treatment for at least 12 months (with a stable dose for = 3 months) prior to screening,
- •Women of childbearing potential agreeing to use a highly effective method of birth control during the entire duration of the trial and for 4 weeks following the last dose of trial treatment, defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptive methods, some intrauterine devices (IUD), sexual abstinence, or vasectomized partner. Women of non-childbearing potential (surgically sterile [e.g., hysterectomy, bilateral salpingectomy, bilateral oophorectomy], or postmenopausal with at least two years without spontaneous menses) may be included. The investigator is responsible for determining whether the patient has adequate birth control for trial 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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •History or presence of any other relevant concomitant liver diseases.
- •Patients taking prohibited medications
- •Liver cirrhosis. NOTE: Patients with compensated cirrhosis and a Child-Pugh Score <8 are allowed to participate,
- •Any known relevant infectious disease (e.g., active tuberculosis, acquired immunodeficiency syndrome [AIDS]-defining diseases),
- •Abnormal renal function (glomerular filtration rate estimated from cystatin C < 30 ml/min) at screening visit,
- •Previous or concurrent cancer except cervical carcinoma in situ, treated basal cell carcinoma, or any cancer curatively treated < 3 years before screening,
- •Existing or intended pregnancy or breast-feeding
研究者
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