Intrahepatic Cholestasis of Pregnancy
Conditions
Brief summary
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.
Interventions
DRUGMaralixibat
Maralixibat 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.
Sponsors
Mirum Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
1. Willing and able to provide signed informed consent at the screening visit 2. 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 3. Have a diagnosis of ICP in line with the AASLD guidelines 4. Willing and able to complete study-related procedures as required
Exclusion criteria
1. At the time of the screening/baseline visit, decision has already been made to deliver within the next 7 days, for any indication. 2. 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 3. Known non-reassuring fetal status based upon antepartum testing (e.g., CTG (cardiotography) at or within 7 days prior to screening/baseline visit 4. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life 5. 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.) 6. Evidence of other hepatobiliary conditions at screening or baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | From first dose until approximately 42 days after delivery. |
Contacts
CONTACTClinical Trials Mirum
CONTACTMedinfo Mirum
Outcome results
None listed