Maralixibat for the trEatment of inTrAhePatic cHOlestasis of pRegnancy (METAPHOR)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Assess the Safety and Tolerability of Maralixibat in Participants With ICP
研究概览
简要总结
An open label phase 2a/b trial of maralixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Provide signed informed consent and be willing to comply with all study visits and requirements through end of study, including the follow-up period
- •Female aged ≥18 and ≤50 years with a viable singleton pregnancy between 20 weeks 0 days and 34 weeks 0 days (inclusive) at the screening visit, and no more than 35 weeks 0 days (inclusive) at the baseline visit.
- •Diagnosis of ICP
- •Non fasting (e.g., postprandial) tSBA level ≥19 μmol/L as assessed by the local laboratory.
- •Meets all inclusion criteria and no
排除标准
- •at screening as well as at the Day 1 (baseline) visit, unless otherwise specified.
- •Exclusion Criteria:
- •At the time of either the screening or baseline visit, decision has already been made to deliver within the next 7 days, for any indication.
- •Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG) at or within 7 days before the baseline visit.
- •Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.
- •Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.
研究组 & 干预措施
Maralixibat
Dose-titrated open-label maralixibat, with primary assessment at Week 3; participants may continue treatment until delivery
干预措施: Maralixibat (Drug)
结局指标
主要结局
Assess the Safety and Tolerability of Maralixibat in Participants With ICP
时间窗: Through to end of treatment, up to 21 weeks
To assess the safety and tolerability of maralixibat in participants with ICP on the basis of the following endpoints: Proportion of participants experiencing one or more of the following: To assess the safety and tolerability of maralixibat for the treatment of intrahepatic cholestasis of pregnancy (ICP) in pregnant women. Incidence of adverse events (AEs), serious adverse events (SAEs), and AEs that lead to discontinuation Incidence of clinically relevant laboratory abnormalities .
次要结局
- Mean Change in the Weekly Average Worst Daily Itch Score as Measured by the Adult Itch Reported Outcome (5-D Itch Scale)(Through the end of treatment (up to 21 weeks).)
- Mean Change in Total Serum Bile Acid (tSBA) Concentration(Baseline to Week 3 (minimum 7 days of treatment))