EUCTR2015-001157-32-GB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 - A4250 in paediatric cholestasis
适应症
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
入选标准
- •The main inclusion criteria for study participation eligibility will be:
- •Diagnosis of pruritus due to chronic cholestasis based on history and investigator judgment
- •o This will include but will not be restricted to patients with Progressive familial
- •intrahepatic cholestasis (PFIC), Alagille syndrome (ALGS), Biliary Atresia and
- •Sclerosing Cholangitis
- •Laboratory markers of cholestasis identified within 3 months before Visit 1
- •Serum total bile acids at least 2 times above upper limit of normal
- •A VAS-itch of at least 3 (average of 7 days) 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 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
排除标准
- •The main exclusion criteria for study participation eligibility will be:
- •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 than chronic cholestasis 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 a 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 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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