NCT06095986撤回2 期
A Proof of Concept, Prospective, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients With Primary Sclerosing Cholangitis
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change from Baseline in serum alkaline phosphatase (ALP)
研究概览
简要总结
The objectives of this study is to Evaluate the Safety, Tolerability, and Efficacy of Aramchol Meglumine in Patients with Primary Sclerosing Cholangitis
详细描述
The objectives of this study are to:
- Establish the safety and tolerability of once daily (QD) Aramchol meglumine in patients with PSC
- Examine whether once daily (QD) Aramchol meglumine has any effect on serum alkaline phosphatase
- Provide a comprehensive readout of clinical efficacy following once daily (QD) Aramchol meglumine administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 18 years and above (inclusive at first screening visit)
- •Established diagnosis of large duct PSC based on abnormal cholangiography as assessed by magnetic resonance cholangiopancreatography (MRCP) or Endoscopic retrograde cholangiopancreatography (ERCP)
- •Alkaline phosphatase > 150 IU/l
- •Stable inflammatory bowel disease therapy > 3months for IBD patients
- •If receiving treatment with Ursodeoxycholic acid (UDCA; ursodiol), therapy is at a dose of <20 mg/kg/day, has been stable for at least 6 months before screening
- •Ability to understand the nature of the study and to sign a written informed consent form (ICF)
排除标准
- •Other causes of liver disease, including secondary sclerosing cholangitis or viral, metabolic, or alcoholic liver disease, as assessed clinically
- •Active Crohn's disease (CDAI > 40) or ulcerative colitis (Mayo IBD score > 4) or active non-hemorrhoidal rectal bleeding
- •Small bowel resection > 100 cm
- •Cirrhosis (clinically evident or by biopsy)
- •Prior hepatic decompensation event
- •Recent (< 6 weeks) acute cholangitis or hospitalization for PSC or IBD
- •Bleeding diathesis or other contraindication for liver biopsy
- •Known GI or hepatobiliary malignancy
- •Prior liver transplantation
- •Prior exposure to study drug
- •Active untreated viral hepatitis or other concomitant liver disease
研究组 & 干预措施
PSC patients administered with Aramchol meglumine
Active Comparator
Adult subjects with clinically diagnosed PSC that are administered with Aramchol meglumine
干预措施: Aramchol meglumine (Drug)
PSC patients administered with placebo
Placebo Comparator
Adult subjects with clinically diagnosed PSC that are administered with matching placebo
干预措施: Aramchol meglumine (Drug)
结局指标
主要结局
Change from Baseline in serum alkaline phosphatase (ALP)
时间窗: 48 weeks
The change from Baseline to Week 48 in ALP levels
次要结局
- Change from Baseline in hepatobiliary fibrosis using the Nakanuma staging scale(48 weeks)
- Change from Baseline in the revised Mayo risk score (rMRS)(48 weeks)
- Change from Baseline in Enhanced liver fibrosis (ELF)(48 weeks)
- Change from Baseline in MRCP(48 weeks)
- Change from Baseline in quantitative liver function using Gadoxetate clearance(48 weeks)
- Change from Baseline in 5D-itch scale(48 weeks)
- Change from Baseline to Week 48 in Patient-Reported Outcomes Measurement Information System (PROMIS)-19 score(48 weeks)
- Change from Baseline in the Mayo IBD symptom severity score(48 weeks)
- Change from Baseline in the UK-PSC score(48 weeks)
- Change from Baseline in the PSC risk estimate tool (PREsTo)(48 weeks)
研究者
研究点 (1)
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