EUCTR2014-005558-21-GB进行中（未招募）1 期
A Pilot, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients with Primary Sclerosing Cholangitis (PSC) - CAMEO STUDY
umena Pharmaceuticals LLC0 个研究点目标入组 20 人开始时间: 2015年1月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
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
- •To participate in this study subjects must meet all of the following criteria:
- •1. Male or female subjects between the ages of 18-80 years, inclusive.
- •2. Diagnosis of PSC consistent with American Association for the Study of Liver Disease (AASLD) (Chapman, et al., 2010), which includes the documented history of the following diagnostic factors:
- •a. Alkaline phosphatase >1.5 x ULN.
- •b. Magnetic resonance cholangiography (MRC), or endoscopic retrograde cholangiography (ERC), or percutaneous transhepatic cholangiography (PTC) demonstrating intrahepatic and/or extrahepatic biliary obstruction, beading, or narrowing consistent with PSC.
- •c. If liver biopsied previously, histological findings with features consistent with or diagnostic of PSC.
- •3. If inflammatory bowel disease (IBD) is present, disease activity = 2 (normal to moderate), using the physician assessment on the Mayo ulcerative colitis (UC) disease activity score.
- •4. Patients receiving azathioprine for intestinal bowel disease are eligible to participate in the study provided that they have had no IBD exacerbations for at least 6 months.
- •5. Females of childbearing potential must have a negative serum pregnancy test [ß human chorionic gonadotropin (ß-hCG)] during screening and negative urine pregnancy test at the baseline/Day 0 visit.
- •6. Sexually active females must be postmenopausal, surgically sterile, or if premenopausal, be prepared to use an effective method (= 1% failure rate) of contraception during the trial. Effective methods of contraception are considered to be:
- •a. Hormonal (e.g., contraceptive pill, patch, intramuscular implant or injection) provided subject has been on stable therapy for at least 3 months; or
- •b. Barrier method, i.e., (a) condom (male or female) or (b) diaphragm, with spermicide; or
- •c. Intrauterine device (IUD); or
- •d. Vasectomy (partner).
- •7. Ability to read and understand English in order to use the study-related questionnaires and the text on the eDiary screen.
- •8. Must be willing and able to use an eDiary daily for a minimum of 20 weeks.
- •9. Must digitally accept the licensing agreement in the eDiary software at the outset of the study.
- •10. Must complete at least 10 eDiary Adult ItchRO reports (AM or PM) during each of two consecutive weeks of the screening period prior to allocation to treatment (maximum possible reports = 14 per week).
- •11. Access to phone for scheduled calls from study site.
- •12. Must agree to comply with the study protocol procedures and provide written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •Subjects will be excluded from the study if they meet any of the following criteria:
- •1. Small duct PSC (clinical biochemical and histological features compatible with PSC, but having a normal cholangiogram).
- •2. Presence of a dominant stricture unless brushings and/or biopsies of the stricture are negative for dysplasia or malignancy within 6 months of screening.
- •3. Surgical or endoscopic biliary tree interventions for treatment of clinically significant strictures within 6 months of screening.
- •4. IBD flare (Mayo UC disease activity score > 5 including endoscopic evaluation) within 3 months prior to screening.
- •5. Secondary cause of sclerosing cholangitis (e.g., choledocholithiasis, post-surgical biliary stricture, intra-arterial chemotherapy, recurrent pancreatitis, IgG4-associated cholangiopathy, AIDS cholangiopathy).
- •6. AST or ALT = 5 x ULN at screening.
- •7. History or presence of any other concomitant significant liver disease as assessed by the Investigator, including:
- •a. Hepatitis B infection (HBsAg positive).
- •b. Hepatitis C infection (antibody positive); patients with a positive antibody test will be eligible if there is documented history of negative HCV RNA and not previously treated for HCV.
- •c. Any other cholestatic liver disease [e.g., primary biliary cirrhosis (PBC)].
- •d. Alcoholic liver disease.
- •e. Proven overlap autoimmune hepatitis.
- •f. Proven non-alcoholic steatohepatitis (NASH).
- •8. Presence of advanced clinical complications of PSC or clinically significant hepatic decompensation, including:
- •a. History of liver transplantation, current placement on a liver transplant list or current Model for End Stage Liver Disease (MELD) score = 15.
- •b . Hepatic encephalopathy.
- •c . Hepatorenal syndrome (type I or II) or screening serum creatinine >2.00 mg/dL (177 µmol/L).
- •d. Recurrent variceal bleeding.
- •e. Refractory ascites.
- •9. History or presence of any other disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs, including bile salt metabolism in the intestine [e.g., untreated celiac disease, terminal ileum resection, or gastric bypass procedures (gastric lap band is acceptable) cystic fibrosis, Wilson’s disease.
- •10. Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget’s disease).
- •11. Known history of human immunodeficiency virus (HIV) infection.
- •12. The anticipated need for a surgical procedure within 20 weeks from randomization.
- •13. Any female who is pregnant or lactating or who is planning to become pregnant within 20 weeks of randomization.
- •14. History of cancer, except for basal or squamous cell carcinoma of the skin, or with any laboratory or physical exam or diagnostic procedure finding suggestive of current malignancy.
- •15. Family history of any documented hereditary cancer syndrome.
- •16. History of alcohol or other substance abuse within 1 year prior to screening.
- •17. Administration of the following medications:
- •a. Within 12 months prior to treatment: rituximab.
- •b . Within 6 months prior to treatment: hydroxychloroquine, methotrexate, oral vancomycin, colchicine, bezafibrate/fenofibrate, anti-TNF therapies, leflunomide, tocilizumab, or = 10 mg prednisone (or equivalent); (topical, inhaled, or short course therapy for intercurrent illness are permitted).
- •c. Within 28 days prior to treatment: UDCA, bile acid resins.
- •18. Receipt of an investigational drug, biologic, or medic
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