[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622854":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":24,"locations":30,"responsibleParty":52,"collaborators":54,"id":58,"slug":59,"hasResults":60,"nctId":61,"briefTitle":62,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":60,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":19,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":88,"whyStopped":19,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Imperial College London","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Maralixibat","EXPERIMENTAL","Dose-titrated open-label maralixibat, with primary assessment at Week 3; participants may continue treatment until delivery",[13],"Drug: Maralixibat",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DRUG","Oral solution, dose-titrated. Maralixibat is an ileal bile acid transporter (IBAT) inhibitor.",[9],null,[21],{"name":22,"affiliation":5,"role":23},"Catherine Williamson, MD","PRINCIPAL_INVESTIGATOR",[25],{"name":26,"role":27,"phone":28,"phoneExt":19,"email":29},"Jenny Chambers","CONTACT","07843 660349","jenny.chambers@imperial.ac.uk",[31,43],{"facility":32,"status":19,"city":33,"state":19,"zip":34,"country":35,"countryCode":36,"cosmosGeoPoint":37,"geoPoint":42,"contacts":19},"Birmingham Womens and Childrens NHS Foundation Trust","Birmingham","B15 2TG","United Kingdom","UK",{"type":38,"coordinates":39},"Point",[40,41],-1.89983,52.48142,{"lat":41,"lon":40},{"facility":44,"status":19,"city":45,"state":19,"zip":46,"country":35,"countryCode":36,"cosmosGeoPoint":47,"geoPoint":51,"contacts":19},"Guy's and St Thomas' NHS Foundation Trust","London","SE 1 7EH",{"type":38,"coordinates":48},[49,50],-0.12574,51.50853,{"lat":50,"lon":49},{"type":53,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[55],{"name":56,"class":57},"Mirum Pharmaceuticals, Inc.","INDUSTRY","100622854","phase-2-maralixibat-for-intrahepatic-cholestasis-of-pregnancy-100622854",false,"NCT07389031","Maralixibat for Intrahepatic Cholestasis of Pregnancy","Maralixibat for the trEatment of inTrAhePatic cHOlestasis of pRegnancy (METAPHOR)","METAPHOR","Inclusion Criteria:\n\n1. Provide signed informed consent and be willing to comply with all study visits and requirements through end of study, including the follow-up period\n2. 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.\n3. Diagnosis of ICP\n4. Non fasting (e.g., postprandial) tSBA level ≥19 μmol\u002FL as assessed by the local laboratory.\n5. Meets all inclusion criteria and no exclusion criteria at screening as well as at the Day 1 (baseline) visit, unless otherwise specified.\n\nExclusion Criteria:\n\n1. 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.\n2. Known non-reassuring fetal status based upon antepartum testing (e.g., NST\u002FCTG) at or within 7 days before the baseline visit.\n3. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.\n4. Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.","FEMALE","18 Years","50 Years",{"count":70,"type":71},28,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","An open label phase 2a\u002Fb trial of maralixibat in patients with Intrahepatic Cholestasis of Pregnancy (ICP) and elevated serum bile acid concentrations (sBA) to evaluate safety and tolerability",[77],"Intrahepatic Cholestasis of Pregnancy",[79,80,81,82,83,84,85,86,87],"Pruritus","Itch","Itching","Cholestasis","Bile Acid","Pregnancy","Pregnant","Intrahepatic","Liver","NOT_YET_RECRUITING","2026-01-28",{"date":91,"type":92},"2026-02-05","ACTUAL",{"date":94,"type":71},"2026-04-01",{"date":96,"type":71},"2028-03-31",{"name":5,"class":6},2]