EUCTR2016-003367-19-IE进行中（未招募）1 期
Double-blind, randomized, placebo-controlled, phase III study comparing norursodeoxycholic acid capsules with placebo in the treatment of primary sclerosing cholangitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 300
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
入选标准
- •1. Signed informed consent.
- •2. Males or females.
- •3. Verified PSC.
- •4. Liver biopsy available.
- •8. Women of child-bearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile, who are sexually active have to apply a highly effective method of birth Control with a low failure rate (i.e., less than 1% per year) when used constantly and correctly such as combined (estrogen and progestogen
- •containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device (IUD), intrauterine hormone-releasing system (IUS), bilateral tubal occlusion, vasectomized
- •partner, or sexual abstinence (only accepted as a highly effective contraceptive measure if it is the usual and preferred lifestyle of the patient), throughout the treatment period and for four weeks following the last dose of study drug. Hormonal methods other than levonorgestrel containing devices or medroxyprogesterone injections should be supplemented with use of a male condom. 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 patient has this adequate birth control for study participation.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 50
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 210
- •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
- •4. Secondary causes of Sclerosing Cholangitis
- •11. Total bilirubin > 4.0 mg/dL (> 68 µmol/L) at screening or baseline.
- •13.Any known relevant infectious disease (e.g., active tuberculosis, AIDS defining diseases).
- •14.Abnormal renal function
- •15.Thyroid-stimulating hormone (TSH) > ULN at screening (elevated levels [4.2-10 µU/mL] are acceptable, if fT4 is measured and within the normal range).
- •16. Any severe concomitant cardiovascular, renal, endocrine, or psychiatric disorder, which in the opinion of the investigator might have an influence on the patient’s compliance or on the interpretation of the results, or patient with atrial fibrillation or any disorder which in the opinion of the investigator may affect the patient’s safety.
- •17.Any active malignant disease.
- •18.Known intolerance/hypersensitivity to study drug, or drugs of similar chemical structure or pharmacological profile.
- •19.Well-founded doubt about the patient's cooperation.
- •20.Existing or intended pregnancy or breast-feeding.
- •21.Participation in another clinical trial within the last 30 days prior to screening visit.
- •22.Patients who have an absolute contraindication for liver biopsy.
- •23.Imprisoned persons, persons admitted to nursing homes, persons under legal guardianship, and persons not able to express their consent (e.g. due to mental impairment).
研究者
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