A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA
A randomized placebo-controlled trial of elafibranor in patients with primary biliary cholangitis and incomplete response to UDCA
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DOI：
10.1016/j.jhep.2021.01.013
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发表时间：
2021-05-14
影响因子：
25.7
通讯作者：
Luketic, Velimir
中科院分区：
文献类型：
--
作者：
Schattenberg, Jorn M.;Pares, Albert;Luketic, Velimir
背景与目的：对熊去氧胆酸有不完全反应的原发性胆管炎（PBC）患者仍有疾病进展的风险。我们研究了双重PPAR α / δ激动剂elafibranor在PBC患者中的安全性和有效性。方法：这项为期12周的双盲II期试验招募了45名对熊去氧胆酸（碱性磷酸酶水平>=正常上限（ULN）的1.67倍）不完全缓解的PBC成人患者。患者被随机分配到80毫克、120毫克或安慰剂组。主要终点是12周时ALP的相对变化（NCT03124108）。结果：12周时，elafbranor 80 mg组ALP降低-48.3 +/- 14.8% (p
Background & Aims: Patients with primary biliary cholangitis (PBC) who have an incomplete response to ursodeoxycholic acid remain at risk of disease progression. We investigated the safety and efficacy of elafibranor, a dual PPAR alpha/delta agonist, in patients with PBC.Methods: This 12-week, double-blind phase II trial enrolled 45 adults with PBC who had incomplete response to ursodeoxycholic acid (alkaline phosphatase levels >= 1.67-fold the upper limit of normal (ULN). Patients were randomly assigned to elafibranor 80 mg, elafibranor 120 mg or placebo. The primary endpoint was the relative change of ALP at 12 weeks (NCT03124108).Results: At 12 weeks, ALP was reduced by -48.3 +/- 14.8% in the elafibranor 80 mg group (p