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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
28
Oral solution, dose-titrated. Maralixibat is an ileal bile acid transporter (IBAT) inhibitor.
Birmingham Womens and Childrens NHS Foundation Trust
Birmingham, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
Assess the Safety and Tolerability of Maralixibat in Participants With ICP
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 .
Time frame: Through to end of treatment, up to 21 weeks
Mean Change in the Weekly Average Worst Daily Itch Score as Measured by the Adult Itch Reported Outcome (5-D Itch Scale)
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)
Time frame: Through the end of treatment (up to 21 weeks).
Mean Change in Total Serum Bile Acid (tSBA) Concentration
Mean change from baseline to Week 3 of the study treatment period in total tSBA concentration (minimum 7 days).
Time frame: Baseline to Week 3 (minimum 7 days of treatment)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.