EUCTR2015-001157-32-DE进行中（未招募）1 期
An exploratory Phase II Study to demonstrate the Safety and Efficacy of A4250 in Children with Cholestatic Pruritus.Short title: A4250 in paediatric cholestasis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Albireo AB
- 入组人数
- 24
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
- •The inclusion criteria for study participation eligibility are:
- •Diagnosis of pruritus due to chronic cholestasis based on history and Investigator judgment
- •-> This will include but will not be restricted to patients with PFIC, ALGS, Biliary Atresia and Sclerosing Cholangitis
- •Laboratory markers of cholestasis identified within 3 months of Visit 1
- •Serum total bile acids at least 2 times above upper limit of normal
- •The patient has a VAS-itch of at least 3 on a 10-graded VAS at Visit 2
- •The caretaker/patient reports having understood and has signed the ICF and is willing to comply with all study visits and assessments;
- •The patient is a male or non-pregnant female =12 months of age and <18 years of age with a body weight exceeding 7 kg
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •The exclusion criteria for study participation eligibility are:
- •Any condition that, in the opinion of the Investigator constitutes a risk for the patient or a contraindication for participation and completion of the study, or could interfere with study objectives, conduct, or evaluations.
- •Clinical or biochemical signs of decompensated liver disease (such as ascites)
- •Liver transplantation
- •Structural abnormality of the GI tract (biliary diversion procedures accepted).
- •Known, active, clinically significant acute or chronic infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infective treatment within 4 weeks of treatment start (study day 1) or completion of oral anti-infective treatment within 2 weeks prior to start of screening period;
- •A history of cancer with last date of proven disease activity/presence of malignancy within 5 years, except for adequately treated basal cell carcinoma of the skin, cervical dysplasia, or carcinoma in situ of the skin or the cervix
- •Other reason for pruritus such as treatment refractory atopic dermatitis, other primary skin diseases etc.
- •Treatment with bile acid sequestrants (cholestyramine, colesevelam, colestipol or similar) during the screening period
- •Chronic kidney disease with an impaired renal function and GFR<70 ml/min1.73 m2
- •Active substance abuse in the year before Screening
- •A history of a psychiatric disorder requiring hospitalization or suicide attempt in the 2 years prior to Screening;
- •Participation in any investigational clinical study, with the exception of the low dose of this study, within 30 days prior to Screening, or plans to participate in another clinical study during this study;
- •Ongoing pregnancy, breast-feeding or lactation.
研究者
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