EUCTR2014-004693-42-IT进行中（未招募）1 期
A Multicenter, Open-Label, Single- and Multiple-Dose, Dose-Finding Study, with an Optional Open-Label Extension to Assess the Safety, Tolerability and Pharmacokinetics of Obeticholic Acid in Pediatric Subjects with Biliary Atresia - ObetiCholic Acid in Pediatric Subjects with BiliaRy AtrEsia (CARE)
INTERCEPT PHARMACEUTICALS INC.0 个研究点目标入组 32 人开始时间: 2022年9月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female pediatric subjects, aged =2 to <18 years old
- •2. Diagnosis of biliary atresia
- •3. Demonstrated successful HPE (also known as a Kasai
- •portoenterostomy) as defined by total bilirubin <2 mg/dL (34.2 µmol/L)
- •at least 3 months post-HPE procedure.
- •4. Able to swallow tablets (ie, tablet or mini-tablet formulation)
- •Please refer to the protocol for the entire list of inclusion criteria.
- •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.Prior liver transplant or active status on transplant list
- •2.Conjugated (direct) bilirubin =ULN of site specific reference range
- •3.If conjugated bilirubin is not available: total bilirubin =2 mg/dL (34.2
- •4.Platelets <150,000/µL
- •5.INR =1.5
- •6.Current or history of complications of decompensated chronic liver
- •disease including:
- •a)High-risk gastroesophageal varices and/or varcieal bleeding
- •b)Clinically evident ascites related to portal hypertension
- •c)Hepatic encephalopathy
- •d)Prior placement of portosystemic shunt
- •e)Hepatopulmonary syndrome or portopulmonary hypertension
- •f)Hepatorenal syndrome
- •7.Current intractable pruritus or those requires systemic treatment for
- •pruritus within 3 months of Screening (eg, with bile acid sequestrants or
- •rifampicin)
- •8.Height and weight Z-score <-2 per site specific reference ranges
- •9.Acholic (pale) stools
- •10.AST >4x ULN
- •11.ALT > 4X ULN
- •12.GGT > 500 U/L
- •13.Anticoagulation therapy
- •14.Albumin < 3.5 g/Dl
- •15.Ongoing current cholangitis
- •16.Choledochal cystic disease
- •17.Renal disease defined as serum creatinine >ULN for subject's age,
- •prior to enrollment
- •Please refer to the protocol for the entire list of exclusion criteria.
研究者
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