EUCTR2016-003817-80-ES进行中（未招募）1 期
A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Elafibranor at Doses of 80 mg and 120mg after 12 Weeks of Treatment in Patients With Primary Biliary Cholangitis (PBC) and Inadequate Response to Ursodeoxycholic Acid
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Genfit SA
- 入组人数
- 45
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. Must have provided written informed consent (IC)
- •2. Males or females 18 to 75 years of age
- •3. Definite or probable PBC diagnosis as demonstrated by the presence of at least 2 of the following 3 diagnostic factors:
- •o History of elevated ALP levels for at least 6 months prior to Day 0 (randomization visit)
- •o Positive Anti-Mitochondrial Antibodies (AMA) titers (> 1/40 on immunofluorescence or M2 positive by enzyme-linked immunosorbent assay (ELISA) or positive PBC-specific antinuclear antibodies
- •o Liver biopsy consistent with PBC
- •4. ALP = 1.67x upper limit of normal (ULN)
- •5. Taking UDCA for at least 12 months (stable dose for = 6 months) prior to screening visit
- •6. Contraception: Females participating in this study must be of non-childbearing potential or must be using highly efficient contraception for the full duration of the study and for 1 month after the end of treatment, as described below:
- •a) Cessation of menses for at least 12 months due to ovarian failure
- •b) Surgical sterilization such as bilateral oopherectomy, hysterectomy, or medically documented ovarian failure
- •c) If requested by local IRB regulations and/or National laws, sexual abstinence may be considered adequate (the reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject)
- •d) Using a highly effective non-hormonal method of contraception (bilateral tubal occlusion, vasectomised partner or intra-uterine device)
- •e) Double contraception with barrier and highly effective hormonal method of contraception (oral, intravaginal or transdermal combined estrogen and progestogen hormonal contraception associated with inhibition of ovulation, oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation or intrauterine hormone-releasing system). The hormonal contraception must be started at least one month prior to randomization.
- •7. Must agree to comply with the trial protocol.
- •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 32
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 13
排除标准
- •1. History or presence of other concomitant liver diseases including:
- •Hepatitis B or C virus (HCV, HBV) infection
- •Primary sclerosing cholangitis (PSC)
- •Alcoholic liver disease
- •Definite autoimmune liver disease or overlap hepatitis
- •Nonalcoholic steatohepatitis (NASH)
- •Gilbert's Syndrome (due to interpretability of bilirubin levels)
- •Known history of alpha-1 antitrypsin deficiency
- •2. Screening CPK > ULN
- •3. Screening ALT or AST > 5 ULN
- •4. Screening total bilirubin > 2 ULN
- •5. Screening serum creatinine > 1.5 mg/dl
- •6. Significant renal disease, including nephritic syndrome, chronic kidney disease (defined as patients with markers of kidney damage or estimated glomerular filtration rate [eGFR] of less than 60 mL/min/1.73 m2).
- •7. Patients with moderate or severe hepatic impairment (defined as Child-Pugh B/C)
- •8. Platelet count <150 X 10 3/microliter
- •9. Albumin <3.5 g/dL
- •10. Presence of clinical complications of PBC or clinically significant hepatic decompensation, including:
- •History of liver transplantation, current placement on a liver transplant list, or current Model for End Stage Liver Disease (MELD) score = 15
- •Patients with cirrhosis/portal hypertension and complications (or signs and symptoms of cirrhosis/portal hypertension), including known esophageal varices, poorly controlled or diuretic resistant ascites, history of variceal bleeds or related interventions (e.g., insertion of variceal bands or transjugular intrahepatic portosystemic shunts [TIPS]), and hepatic encephalopathy, history or presence of spontaneous bacterial peritonitis, hepatocellular carcinoma
- •Hepatorenal syndrome (type I or II) or screening serum creatinine > 2 mg/dL (178 µmol/L)
- •11. Administration of the following medications is prohibited as specified below:
- •2 months preceding screening and throughout the trial (up to the last study visit):: fibrates or obeticholic acid, glitazones
- •3 months prior to screening and throughout the trial (up to the last study visit) ): azathioprine, colchicine, cyclosporine, methotrexate, mycophenolate mofetil, pentoxifylline; budesonide and other systemic corticosteroids; and potentially hepatotoxic drugs (including a-methyl-dopa, sodium valproic acid, isoniazide, or nitrofurantoin)
- •12 months prior to inclusion visit and throughout the trial (up to the last study visit): antibodies or immunotherapy directed against interleukins or other cytokines or chemokines
- •12. If female: known pregnancy, or has a positive urine pregnancy test (confirmed by a positive serum pregnancy test), or lactating
- •13. Known history of human immunodeficiency virus (HIV) infection
- •14. Medical conditions that may cause non-hepatic increases in ALP (e.g., Paget's disease)
- •15. Other clinically significant medical conditions that are not well controlled or for which medication needs are anticipated to change during the trial
- •16. Anticipated changes to current medications (that will be continued) during the course of the trial
- •17. History of alcohol abuse, defined as consumption of more than 30 g pure alcohol per day for men, and more than 20 g pure alcohol per day for women, or other substance abuse within 1 year prior to Day 0 (randomization visit)
- •18. Participation in another trial with an investigational drug, biologic, or medical device using active substance within 30 days prior to screening, or within 5 half lives of the active substance, whichever is longer.
- •19. History of noncompliance with medical regimens, or patients who are con
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