NL-OMON53035撤回2 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.;Trial Acronym: ObetiCholic Acid in Pediatric Subjects with BiliaRy AtrEsia (CARE) - ObetiCholic Acid in Pediatric Subjects with BiliaRy AtrEsia (CARE)
Intercept Pharmaceuticals Inc.0 个研究点目标入组 5 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 入组人数
- 5
研究概览
简要总结
Trial never started
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 2 至 17（—）
入选标准
- •1. Male or female pediatric subjects >=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
- •4. Able to swallow tablets (i.e., tablet or mini-tablet formulations)
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 availble: total bilirubin >=2 mg/dL (34.2 µmol/
- •4. Platelets <150,000/µL.
- •5. INR >=1.5.
- •6. Current or history of complications of decompensated chronic liver disease
- •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 requires systemic treatment for pruritus
- •within 3 months of Screening (e.g., 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. Gamma-glutamyl transferase (GGT) >500 U/L
- •13. Anticoagulation therapy
- •14. Albumin <3.5 g/dL
研究者
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