EUCTR2018-003365-34-IT进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Study Evaluating the Efficacy and Safety of Baricitinib (LY3009104) in Patients with Primary Biliary Cholangitis Who Have an Inadequate Response or are Intolerant to UDCA. - na
ELI LILLY & COMPANY, LILLY CORPORATE CENTER0 个研究点目标入组 2 人开始时间: 2021年8月3日最近更新:
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试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2
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
- •Type of Patient and Disease Characteristics
- •[1] Male or female patients who are at least 18 years of age.
- •[2] Have a diagnosis of PBC (consistent with American Association for
- •the Study of Liver Disease [AASLD] and European Association for Study
- •of the Liver [EASL]
- •Practice Guidelines; [Lindor 2009; EASL 2017]), as demonstrated by the
- •presence of at least 2 of the following 3 diagnostic factors:
- •¿ History of elevated ALP levels for at least 6 months
- •¿ Positive antimitochondrial antibodies titer
- •¿ Liver biopsy consistent with PBC
- •[3] Have ALP =1.67 x ULN but <6 x ULN
- •[4] Taking UDCA for at least 52 weeks (stable dose for at least 12
- •weeks) prior to Visit 3
- •(Week 0), or have previously taken, but are intolerant (in the opinion of
- •the investigator) to UDCA and have not received UDCA for at least 12
- •prior to Visit 3 (Week 0).
- •Patient Characteristics
- •[5] Nonpregnant, nonbreastfeeding female patients of childbearing
- •a. Patients who are abstinent (if this is complete abstinence, as their
- •preferred and usual lifestyle) or in a same-sex relationship (as part of
- •preferred and usual lifestyle) must agree to either remain abstinent or
- •stay in a same-sex relationship without sexual relationships with the
- •opposite sex during the entirety of the study and for at least 1 week
- •following the last dose of investigational product.
- •Total abstinence is defined as refraining from intercourse during the
- •entirety of the study and for at least 1 week following the last dose of
- •investigational product. Periodic abstinence such as calendar, ovulation,
- •symptothermal, postovulation methods, and withdrawal are not
- •acceptable methods of contraception b. Otherwise, patients must agree
- •to use for the entirety of the study and for at least 1 week following the
- •last dose of investigational product, 2
- •effective methods of contraception, where at least 1 form is highly
- •effective (such as combination oral contraceptives, implanted
- •contraceptives or
- •intrauterine devices). Effective contraception (such as male or female
- •condoms with
- •spermicide, diaphragms with spermicide or cervical sponges) may be
- •used as the second therapy. Barrier protection methods without
- •concomitant
- •use of a spermicide are not a reliable or acceptable method.
- •Female patients of nonchildbearing potential may participate without
- •requirements for contraception. This includes female patients who are:
- •a. Infertile due to surgical sterilization (hysterectomy, bilateral
- •oophorectomy,
- •or tubal ligation), congenital anomaly such as mullerian agenesis; or
- •b. Postmenopausal – defined as either
- •i. A woman at least 50 years of age with an intact uterus, not on
- •hormone therapy, who has had either
- •1. Cessation of menses for at least 1 year, or
- •2. At least 6 months of spontaneous amenorrhea with a
- 另有 11 项未显示
排除标准
- •[7] History or presence of other concomitant liver diseases including:
- •a. Hepatitis C virus (HCV) infection (hepatitis C antibody-positive and
- •HCV ribonucleic acid [RNA] positive). ¿ Note: Patients who have
- •documented anti-HCV treatment for a past HCV infection AND are HCV
- •RNA-negative with a sustained viral response may be enrolled in the
- •b. Hepatitis B virus (HBV) infection defined as:
- •¿ positive for hepatitis B surface antigen (HBsAg), or
- •¿ positive for hepatitis B core antibody (HBcAb)
- •c. Primary sclerosing cholangitis
- •d. Alcoholic liver disease
- •e. Autoimmune liver disease other than PBC, such as overlap hepatitis
- •f. Nonalcoholic steatohepatitis
- •g. Gilbert's syndrome
- •[8] Presence of clinical complications of PBC or clinically significant
- •hepatic decompensation, including:
- •a. Liver transplantation, current placement on a liver transplant list or
- •current Model for End Stage Liver Disease (MELD) score = 15
- •b. Portal hypertension with complications, including known gastric or
- •esophageal varices, ascites, history of variceal bleeds or related
- •therapeutic
- •or prophylactic interventions (e.g., beta blockers, insertion of variceal
- •bands or transjugular intrahepatic portosystemic shunt), or hepatic
- •encephalopathy
- •c. Cirrhosis, including history or presence of one or more of the
- •following: spontaneous bacterial peritonitis, hepatocellular carcinoma
- •d. Hepatorenal syndrome (type I or II)
- •[9] Have an estimated glomerular filtration rate (eGFR) based on the
- •most recent available serum creatinine of <90 mL/min/1.73 m2.
- •[10] Have screening electrocardiogram (ECG) abnormalities that in the
- •opinion of the investigator or the sponsor are clinically significant and
- •indicate an unacceptable risk for the patient's participation in the study.
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