EUCTR2019-003807-37-BE进行中（未招募）1 期
A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Odevixibat (A4250) in Children with Biliary Atresia Who Have Undergone a Kasai Hepatoportoenterostomy (BOLD)
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
- 245
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. A male or female patient with a clinical diagnosis of BA
- •2. Age at Kasai HPE =90 days
- •3. Eligible to start treatment within 3 weeks post-Kasai HPE
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 245
- •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
- •- Patients with intractable ascites
- •- Ileal resection surgery
- •- ALT =10× upper limit of normal (ULN) at screening
- •- Patient on total parenteral nutrition, or not able to take study drug orally, at randomization
- •- Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
- •- Choledochal cystic disease
- •- INR >1.6 (the patient may be treated with Vitamin K intravenously; sample may be redrawn and if INR is =1.6 at resampling the patient may be randomized)
- •- Any other conditions or abnormalities, including congenital abnormalities, major cardiac surgery, hepatic, biliary, or GI disease which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the patient, the integrity of study results, or patient compliance with study requirements
- •- Weight < 3.5kg at randomization
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