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.
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
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
Single group
Maralixibat
DrugMaralixibat tablets: 10 mg and 15 mg. Maralixibat oral solution 20 mg/mL. Maralixibat administered orally once or twice daily, with dose adjustments based on response and tolerability, from enrollment until delivery.
Incidence of treatment-emergent adverse events (TEAEs)
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This trial is not recruiting at the moment. You can still explore other options:
