[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656142":3},{"organization":4,"outcomesModule":7,"designInfo":13,"detailedDescription":11,"studyPopulation":11,"armGroups":19,"interventions":26,"overallOfficials":11,"centralContacts":32,"locations":11,"responsibleParty":41,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":45,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":11,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":11},{"fullName":5,"class":6},"Mirum Pharmaceuticals, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Incidence of treatment-emergent adverse events (TEAEs)",null,"From first dose until approximately 42 days after delivery.",{"allocation":14,"interventionModel":15,"interventionModelDescription":11,"primaryPurpose":16,"observationalModel":11,"timePerspective":11,"maskingInfo":17},"NA","SINGLE_GROUP","TREATMENT",{"masking":18,"maskingDescription":11,"whoMasked":11},"NONE",[20],{"label":21,"type":22,"description":23,"interventionNames":24},"Maralixibat Treatment","EXPERIMENTAL","Participants will receive maralixibat tablets or oral solution.",[25],"Drug: Maralixibat",[27],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":11},"DRUG","Maralixibat","Maralixibat tablets: 10 mg and 15 mg. Maralixibat oral solution 20 mg\u002FmL. Maralixibat administered orally once or twice daily, with dose adjustments based on response and tolerability, from enrollment until delivery.",[21],[33,38],{"name":34,"role":35,"phone":36,"phoneExt":11,"email":37},"Clinical Trials Mirum","CONTACT","+16506674085","clinicaltrials@mirumpharma.com",{"name":39,"role":35,"phone":11,"phoneExt":11,"email":40},"Medinfo Mirum","medinfo@mirumpharma.com",{"type":42,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100656142","phase-2-mrx-901-an-open-label-study-to-assess-safety-and-tolerability-of-maralixibat-in-participants-with-intrahepatic-cholestasis-of-pregnancy-icp-100656142",false,"NCT07823127","MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP)","MRX-901: An Open-label Study to Assess Safety and Tolerability of Maralixibat in Participants With Intrahepatic Cholestasis of Pregnancy (ICP) (OASIS)","OASIS","Inclusion Criteria:\n\n1. Willing and able to provide signed informed consent at the screening visit\n2. 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\u002Fbaseline visit\n3. Have a diagnosis of ICP in line with the AASLD guidelines\n4. Willing and able to complete study-related procedures as required\n\nExclusion Criteria:\n\n1. At the time of the screening\u002Fbaseline visit, decision has already been made to deliver within the next 7 days, for any indication.\n2. 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\n3. Known non-reassuring fetal status based upon antepartum testing (e.g., CTG (cardiotography) at or within 7 days prior to screening\u002Fbaseline visit\n4. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life\n5. Known History or evidence of current undelying cholestatic liver disease at screening\u002Fbaseline (Note: Women with history of ICP or known pathogenic variants that predispose to ICP are considered eligible.)\n6. Evidence of other hepatobiliary conditions at screening or baseline.","FEMALE","18 Years","45 Years",{"count":55,"type":56},15,"ESTIMATED","INTERVENTIONAL",[59],"PHASE2","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).\n\nThis is an open-label study where all participants will receive maralixibat.",[62],"Intrahepatic Cholestasis of Pregnancy","NOT_YET_RECRUITING","2026-09-10",{"date":66,"type":67},"2026-09-16","ACTUAL",{"date":69,"type":56},"2027-01-15",{"date":71,"type":56},"2029-01-12",{"name":5,"class":6}]