NCT03359174终止2 期
An Efficacy Trial of Low Dose All-trans Retinoic Acid (ATRA) in Patients With Primary Sclerosing Cholangitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change of Serum Alkaline Phosphatase (ALP)
研究概览
简要总结
The purpose of this research study is to determine whether a low dose of ATRA will improve laboratory tests of liver and bile duct inflammation in patients with PSC. The investigators will also look for changes to other blood tests which are related to inflammation, scarring, and the immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females ages 18-80
- •Diagnosis of large-duct PSC based on ERCP or MRCP, or liver biopsy findings without alternative explanation for findings, for at least 6 months.
- •Serum ALP levels persistently more than 1.5 x upper limit of normal over the past 6 months.
- •Ursodeoxycholic acid therapy must be discontinued for at least 3 months.
- •At least 2 forms of barrier protection for males and females of child-bearing age.
排除标准
- •Small duct PSC, overlap with autoimmune hepatitis, IgG4 disease or secondary sclerosing cholangitis.
- •Any malignancy, presently or within the past 5 years, except adequately treated non-melanoma skin cancer, carcinoma in situ of the cervix or in situ prostate cancer.
- •Viral hepatitis including hepatitis A, B, C, D, E.
- •Decompensated cirrhosis, or planned liver transplantation.
- •Recent diagnostic or therapeutic biliary manipulation (endoscopic, radiologic) within the past 3 months.
- •Ascending Cholangitis requiring antibiotics within the past 3 months.
- •Uncontrolled IBD, or IBD requiring the use of steroids.
- •Acute or Chronic Kidney Disease with serum creatinine > 2 mg/dL.
- •Allergy to ATRA or vitamin A compounds.
研究组 & 干预措施
All-trans retinoic acid (ATRA) therapy
Experimental
Fixed low dose of ATRA 10 mg twice daily for 24 weeks.
干预措施: All-trans retinoic acid (Drug)
结局指标
主要结局
Change of Serum Alkaline Phosphatase (ALP)
时间窗: Baseline to week 24.
Blood will be drawn at each time point to compare pre- and post-treatment values for each individual.
次要结局
- The Percent of Patients Who Have Reduction of Serum C4 by 50%(Baseline to week 24.)
- The Percent of Patients Who Have Reduction of Serum Bile Acids by 50%(Baseline to week 24.)
- The Percent of Patients Who Have Reduction of Serum Alanine Aminotransferase (ALT) by 50%(Baseline to week 24.)
- The Percent of Patients Who Have Reduction of Serum Enhanced Liver Fibrosis Score (ELF) by 10%(Baseline to week 24.)
- The Percent of Patients Who Have Improvement in Fibrosis Per Transient Elastography by at Least 1 Stage(Baseline to week 24.)
- Change in Patients Who Have Normalization of Serum ALP or Reduction to Less Than 1.5 x Upper Limit of Normal (ULN)(Baseline to week 24.)
研究者
研究点 (1)
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