CTIS2023-505251-43-00招募中1 期
A Phase III Randomised, Parallel-Group, Double-Blind, Placebo-Controlled, Two-Arm Study to Evaluate the Efficacy and Safety of Elafibranor 80 mg on Long-Term Clinical Outcomes in Adult Participants With Primary Biliary Cholangitis (PBC) - CLIN-60190-454
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 387
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Male or female participants must be =18 years of age at the time of signing the informed consent., Participants with a definite or probable diagnosis of primary biliary cholangitis (PBC), Participants taking UDCA for at least 12 months (at a stable dose for =3 months) prior to screening period and expected to remain on stable dose during the study, or unable to tolerate UDCA treatment (no UDCA for =3 months) prior to screening period (per country standard-of-care dosing)., Participants taking medications for management of pruritus (e.g. cholestyramine, rifampin, naltrexone, sertraline or colchicine) must be on a stable dose for =3 months prior to screening period., Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies., Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •History or presence of other concomitant liver disease including but not limited to: i) Primary sclerosing cholangitis (PSC).ii) Autoimmune hepatitis (AIH) by simplified Diagnostic Criteria of the International Autoimmune Hepatitis Group (IAIHG) =6, or if treated for an overlap of PBC with AIH, or if there is clinical suspicion and evidence of overlap AIH features, that cannot be explained alone by insufficient response to UDCA. iii) Positive hepatitis B surface antigen (HBsAg). Participants with negative HBsAg and positive hepatitis B core antibody (HBcAb) may be eligible if hepatitis B virus deoxyribonucleic acid (HBV DNA) is negative. iv) Hepatitis C virus (HCV) infection defined by positive anti-HCV antibody and positive HCV ribonucleic acid (RNA) (Note: Participants with positive anti-HCV antibody due to previously treated HCV infection, may be enrolled if a confirmatory HCV RNA is undetectable and sustained viral response has been documented). v) Alcohol-associated liver disease (ALD). vi) Nonalcoholic steatohepatitis (NASH). vii) Other chronic liver diseases, such as alpha-1 antitrypsin deficiency., Administration of the following medications is prohibited during the study, and prior to the study as per the timelines specified below: i) 3 months prior to screening period: fibrates, seladelpar, glitazones, obeticholic acid, azathioprine, cyclosporine, methotrexate, mycophenolate, pentoxifylline, budesonide and other systemic corticosteroids (parenteral and oral chronic administration only); potentially hepatotoxic drugs (including a-methyl-dopa, sodium valproic acid, isoniazid or nitrofurantoin)., Participants with previous exposure to elafibranor., Participants who are currently participating in, plan to participate in, or have participated in an investigational drug study or medical device study containing active substance within 30 days or 5 half-lives, whichever is longer, prior to the screening period. i) If the previous study was for an experimental therapy being studied for potential benefit in PBC, and the potential therapeutic agent was proven to have no beneficial effect in PBC and there are no safety concerns, the participant may enrol after 30 days or 5 half-lives from the last dose of the therapeutic agent, whichever is longer. ii) For therapeutic agents being studied for potential benefit in PBC for which it is still unclear if there may be a potential benefit, participants may enrol after 6 months from the last dose of the therapeutic agent., Electrocardiogram (ECG) with QT interval corrected by Fridericia’s formula (QTcF) >450 msec in males or QTcF >470 msec in females for participants without bundle branch block. For participants with bundle branch block or other intraventricular conduction delay, a longer QTcF >480 msec would be exclusionary., Total bilirubin (TB) >3x ULN. Participants with Gilbert’s syndrome are eligible with a total bilirubin above 3× ULN if direct bilirubin is <30% of total bilirubin., Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5x ULN at SV1, or variability >40% based on two consecutive values. The interval between the two measurements should be of at leasAlanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5x ULN at SV1, or variability >40% based on two consecutive values. The interval between the two measurements should be of at least 2 weeks (and up to 4 weeks)t 2 weeks (and up to 4 weeks), Creatinine phosphokinase (CPK) >2x ULN., Platelet co
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