EUCTR2014-004693-42-DE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 BiliaryAtresia - ObetiCholic Acid in Pediatric Subjects with BiliaRy AtrEsia (CARE)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 8
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. 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: 32
- •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 µmol/L)
- •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 WHO criteria
- •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
相似试验
进行中（未招募）
1 期
A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body.Biliary atresiaMedDRA version: 20.0Level: LLTClassification code 10004653Term: Biliary atresiaSystem Organ Class: 100000004850MedDRA version: 20.1Level: LLTClassification code 10004654Term: Biliary atresia, congenitalSystem Organ Class: 100000004850EUCTR2014-004693-42-FIIntercept Pharmaceuticals, Inc.72
进行中（未招募）
1 期
A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body including an optional long-term extension.EUCTR2014-004693-42-ITINTERCEPT PHARMACEUTICALS INC.32
进行中（未招募）
1 期
A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body including an optional long-term extension.Biliary atresiaMedDRA version: 20.0Level: LLTClassification code 10004653Term: Biliary atresiaSystem Organ Class: 100000004850MedDRA version: 20.1Level: LLTClassification code 10004654Term: Biliary atresia, congenitalSystem Organ Class: 100000004850EUCTR2014-004693-42-FRIntercept Pharmaceuticals, Inc.32
进行中（未招募）
1 期
A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body including an optional long-term extension.Biliary atresiaMedDRA version: 20.0Level: LLTClassification code 10004653Term: Biliary atresiaSystem Organ Class: 100000004850MedDRA version: 20.1Level: LLTClassification code 10004654Term: Biliary atresia, congenitalSystem Organ Class: 100000004850EUCTR2014-004693-42-BEIntercept Pharmaceuticals, Inc.8
进行中（未招募）
1 期
A study to look at how the study drug Obeticholic Acid (OCA), when given as a single dose and multiple doses, is tolerated in children who have biliary atresia and to look at the effects that the study drug has on the body.EUCTR2014-004693-42-GBIntercept Pharmaceuticals, Inc.72