EUCTR2013-000482-36-GB进行中（未招募）不适用
A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE LUM001, AN APICAL SODIUM-DEPENDENT BILE ACID TRANSPORTER INHIBITOR (ASBTi), IN COMBINATION WITH URSODEOXYCHOLIC ACID (UDCA) IN PATIENTS WITH PRIMARY BILIARY CIRRHOSIS. - CLARITY STUDY
umena Pharmaceuticals, Inc.0 个研究点目标入组 60 人开始时间: 2013年5月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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 subjects between the ages of 18-80 years, inclusive.
- •2. Diagnosis of PBC [consistent with the American Association for the Study of Liver Disease (AASLD, Section 16.3) Practice Guidelines Practice Guidelines; (Lindor, Gershwin, Poupon, Kaplan, Bergasa, & Heathcote, 2009), as demonstrated by the
- •documented history of at least 2 of the following diagnostic factors:
- •a. History of elevated alkaline phosphatase (ALP) levels;
- •b. Presence of anti-mitochondrial antibodies (AMA) with a titer =1:40;
- •c. Liver biopsy consistent with PBC if a biopsy has been performed;
- •d. For patients who are AMA negative, a liver biopsy diagnostic for PBC.
- •3. A previous ultrasound (or equivalent imaging modality) of the biliary tree that excludes biliary obstruction and overt malignancy within 12 months of the screening visit.
- •4. An average daily score > 4.0 on the Adult Itch Reported Outcome (Adult ItchROTM) questionnaire (maximum possible daily score of 10), for each of two consecutive weeks in the screening period using the eDiary.
- •5. Taking ursodeoxycholic acid (UDCA) for at least 6 months (stable dose for = 3 months) prior to Day 0, or unable to tolerate UDCA (no UDCA for = 3 months prior to Day 0).
- •6. If using any of the following medications, must be on a stable dose for the period indicated and expected to remain on the same dose and regimen throughout the treatment period:
- •a. For 30 days prior to screening: rifampin, antihistamines, opiate antagonists;
- •b. For 90 days prior to screening: selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs).
- •7. 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 visit.
- •8. 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).
- •9. Ability to read and understand English or Spanish in order to use the study-related questionnaires.
- •10. Ability to read the text on the eDiary screen.
- •11. Must be willing and able to use an eDiary daily for a minimum of 20 weeks.
- •12. Must digitally accept the licensing agreement in the eDiary software at the outset of the study.
- •13. Must complete at least 10 eDiary Adult ItchRO reports (AM or PM) during each of two consecutive weeks of the screening period prior to randomization (maximum possible reports = 14 per week).
- •14. Access to phone for scheduled calls from study site.
- •15. Must agree to comply with the study protocol 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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. History or presence of 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 sclerosing cholangitis (PSC)];
- •d. Alcoholic liver disease;
- •e. Proven overlap autoimmune hepatitis;
- •f. Proven nonalcoholic steatohepatitis (NASH).
- •2. Presence of advanced clinical complications of PBC 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).
- •3. Total bilirubin > 2 x ULN at screening.
- •4. ALT or AST > 5 x ULN at screening.
- •5. 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., inflammatory bowel disease, celiac disease or gastric bypass procedures (gastric lap band is acceptable)].
- •6. Medical conditions that may cause nonhepatic increases in ALP (e.g., Paget’s disease).
- •7. Known history of human immunodeficiency virus (HIV) infection.
- •8. The anticipated need for a surgical procedure within 20 weeks from randomization.
- •9. Any female who is pregnant or lactating or who is planning to become pregnant within 20 weeks of randomization.
- •10. Cancer within 5 years of screening, except for basal or squamous cell carcinoma of the skin or in situ cervical carcinoma that has been treated with no evidence of recurrence.
- •11. History of alcohol abuse, or other substance abuse within 1 year prior to screening.
- •12.Administration of the following medications:
- •a. For 12 months prior to randomization: rituximab;
- •b. For 90 days prior to randomization: azathioprine, mercaptopurine,
- •mycofenolate, hydroxychloroquine, leflunomide, anti-TNF therapies,
- •tocilizumab;
- •c. For 60 days prior to randomization: = 7.5 mg prednisone (or equivalent); (topical, inhaled, or short course therapy for intercurrent illness are permitted), bezafibrate/fenofibrate;
- •d. For 30 days prior to randomization: methotrexate, bile acid resins (such as cholestyramine), colchicine.
- •13. Receipt of an investigational drug, biologic, or medical device within 30 days prior to screening, or 5 half-lives of the study agent, whichever is longer.
- •14. History of noncompliance with medical regimens, unreliability, mental instability or incompetence that could compromise the validity of informed consent or lead to noncompliance with the study protocol.
- •15.Any other conditions or abnormalities which, in the opinion of the Investigator or Medical Monitor, may compromise the safety of the subject, or interfere with the subject participating in or completing the study.
研究者
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