EUCTR2016-003817-80-GB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
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) ('Inadequate response to UDCA')
- •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:
- •Positive hepatitis B surface antigen (HBsAg) at Screening
- •Positive HCV RNA (tested for in case of known cured HCV infection, or
- •positive HCV Ab at screening)
- •Alcoholic liver disease
- •Primary sclerosing cholangitis (PSC)
- •Definite autoimmune hepatitis (AIH), or 'AIH-PBC overlap syndrome';
- •the existence of AIH is defined as continuing use of budesonide or other
- •systemic corticosteroid therapy, and/or azathioprine, and/or other
- •immunosuppressive therapy following an historical AIH diagnosis (EASL
- •2015). 'AIH-PBC overlap syndrome' is based upon fulfilment of the 'Paris
- •criteria' (Chazouillères 1998) for both AIH (ALT =5x ULN; IgG =2x ULN
- •or smooth muscle antibody; interface hepatitis), and PBC(ALP =2x ULN;
- •AMA, and non-suppurative bile duct injury/destruction), requiring
- •corticosteroid therapy for disease management, either currently or in the
- •Biopsy confirmed Nonalcoholic Steatohepatitis (NASH)
- •Known history of alpha-1 antitrypsin deficiency, or other metabolic
- •forms of chronic liver disease
- •Gilbert's Syndrome (due to interpretability of bilirubin levels)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:
- •Current Model for End Stage Liver Disease (MELD) score = 15; current
- •placement on a liver transplant
- •list, or history of undergoing liver transplantation
- •Any record of complications of cirrhosis and/or portal hypertension
- •o Gastroesophageal variceal bleeding and endoscopic therapy and/or
- •transjugular intrahepatic portosystemic shunt [TIPS] insertion
- •o Ascites formation requiring intervention, e.g. diuretic therapy
- •o Spontaneous bacterial peritonitis
- •o Hepatic encephalopathy
- •o Confirmed or suspected hepatocellular carcinoma
- •11. Hepatorenal syndrome (type I or II) Administration of the following medications is prohibited as specified below:
- •From pre-randomization to EOT or V5 visit: indomethacin
- •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, mycop
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