临床试验/NCT07823127

NCT07823127尚未招募2 期

MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP) (OASIS)

Mirum Pharmaceuticals, Inc.0 个研究点目标入组 15 人开始时间: 2027年1月15日最近更新: 2026年9月16日

适应症

干预措施

试验速览

阶段: 2 期
状态: 尚未招募
发起方: Mirum Pharmaceuticals, Inc.
入组人数: 15
主要终点: Incidence of treatment-emergent adverse events (TEAEs)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者记录与标识符相似试验

研究概览

简要总结

This study is designed to assess whether the investigational drug maralixibat, is safe and well tolerated in pregnant women with intrahepatic cholestasis of pregnancy (ICP).

This is an open-label study where all participants will receive maralixibat.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 45 Years（Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Willing and able to provide signed informed consent at the screening visit
•Female aged ≥18 and ≤45 years with viable singleton pregnancy between 20 weeks 0 days and no more than 35 weeks 0 days (inclusive) gestational age at the screening/baseline visit
•Have a diagnosis of ICP in line with the AASLD guidelines
•Willing and able to complete study-related procedures as required

排除标准

•At the time of the screening/baseline visit, decision has already been made to deliver within the next 7 days, for any indication.
•Known placenta accreta, complete placenta previa, PPROM at any gestational age prior to enrollment, cervical incompetence, history of prior spontaneous birth at ≤34 weeks gestational age not secondary to known or suspected ICP, or other condition (in the opinion of the investigator) likely to result in spontaneous or iatrogenic delivery before 37 weeks gestational age
•Known non-reassuring fetal status based upon antepartum testing (e.g., CTG (cardiotography) at or within 7 days prior to screening/baseline visit
•Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life
•Known History or evidence of current undelying cholestatic liver disease at screening/baseline (Note: Women with history of ICP or known pathogenic variants that predispose to ICP are considered eligible.)
•Evidence of other hepatobiliary conditions at screening or baseline.

研究组 & 干预措施

Maralixibat Treatment

Experimental

Participants will receive maralixibat tablets or oral solution.

干预措施: Maralixibat (Drug)

结局指标

主要结局

Incidence of treatment-emergent adverse events (TEAEs)

时间窗: From first dose until approximately 42 days after delivery.

次要结局

未报告次要终点

研究者

发起方

Mirum Pharmaceuticals, Inc.

申办方类型

Industry

责任方

Sponsor

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