EUCTR2019-003807-37-IT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) - BOLD
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
- 200
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 study treatment within 3 weeks post-Kasai HPE
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •1. Patients with intractable ascites
- •2. Ileal resection surgery
- •3. ALT =10× upper limit of normal (ULN) at screening
- •4. Patient on total parenteral nutrition at randomization
- •5. Acute ascending cholangitis (patients may be randomized after resolution of acute ascending cholangitis)
- •6. Choledochal cystic disease
研究者
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