评估 Maralixibat 用于胆道闭锁患者肝门肠吻合术后治疗有效性和安全性的随机、双盲、安慰剂对照 II期研究。
[Translation] A randomized, double-blind, placebo-controlled phase II study to evaluate the efficacy and safety of Maralixibat in patients with biliary atresia following portoenterostomy.
主要目的是评估 Maralixibat 对胆道闭锁(BA) 患者肝门肠吻合术(HPE)后胆道引流的有效性。次要目的为评估 Maralixibat 治疗后 sBA(血清胆汁酸) 水平的变化,评估 Maralixibat 治疗后胆红素恢复正常的比率,评估 maralixibat 治疗后的无移植生存期,评估 Maralixibat 治疗后胆汁淤积和肝脏疾病的生化指标,以及评估Maralixibat 的安全性、耐受性和药代动力学。
[Translation] The primary objective was to evaluate the effectiveness of Maralixibat for biliary drainage after portoenterostomy (HPE) in patients with biliary atresia (BA). Secondary objectives were to assess changes in sBA (serum bile acid) levels after Maralixibat treatment, assess the rate of bilirubin normalization after Maralixibat treatment, assess graft-free survival after maralixibat treatment, and assess the incidence of cholestasis and liver disease after Maralixibat treatment. Biochemical parameters, and to assess the safety, tolerability and pharmacokinetics of Maralixibat.
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