Intrahepatic Cholestasis of Pregnancy
Conditions
Keywords
Pruritus, Itch, Itching, Cholestasis, Bile Acid, Pregnancy, Pregnant, Intrahepatic, Liver
Brief summary
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
Interventions
DRUGMaralixibat
Oral solution, dose-titrated. Maralixibat is an ileal bile acid transporter (IBAT) inhibitor.
Sponsors
Imperial College London
Mirum Pharmaceuticals, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
1. Provide signed informed consent and be willing to comply with all study visits and requirements through end of study, including the follow-up period 2. 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. 3. Diagnosis of ICP 4. Non fasting (e.g., postprandial) tSBA level ≥19 μmol/L as assessed by the local laboratory. 5. Meets all inclusion criteria and no
Exclusion criteria
at screening as well as at the Day 1 (baseline) visit, unless otherwise specified.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assess the Safety and Tolerability of Maralixibat in Participants With ICP | 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 . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 from baseline to Week 3 (minimum 7 days) of the study treatment period in the weekly average worst daily itch score as measured by the Adult Itch Reported Outcome (5-D Itch Scale) |
| Mean Change in Total Serum Bile Acid (tSBA) Concentration | Baseline to Week 3 (minimum 7 days of treatment) | Mean change from baseline to Week 3 of the study treatment period in total tSBA concentration (minimum 7 days). |
Countries
United Kingdom
Contacts
CONTACTJenny Chambers
PRINCIPAL_INVESTIGATORCatherine Williamson, MD
Imperial College London
Outcome results
None listed