Maralixibat for Intrahepatic Cholestasis of Pregnancy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-50
SponsorImperial College London
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Provide signed informed consent and be willing to comply with all study visits and requirements through end of study, including the follow-up period
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.
Diagnosis of ICP
Non fasting (e.g., postprandial) tSBA level ≥19 μmol/L as assessed by the local laboratory.
Disqualifiers
At the time of either the screening or baseline visit, decision has already been made to deliver within the next 7 days, for any indication.
Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG) at or within 7 days before the baseline visit.
Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.
Participating in another ongoing interventional clinical study at screening or planning to participate in another contemporaneous interventional clinical study while participating in this study.
Trial design
Design model
Single group
Treatments tested in this trial
Maralixibat
DrugOral solution, dose-titrated. Maralixibat is an ileal bile acid transporter (IBAT) inhibitor.
Treatment groups
28 Participants
are divided into 1 treatment groupGroup A: MaralixibatExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSecondary outcomes
1
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).2
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)Other outcomes
1
Proportion of participants with a Composite Adverse Perinatal Outcome
Number of adverse outcomes recorded from baseline to birth visit/end of study
Time frame
Up to 28 days after deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
Imperial College London
Lead sponsor
Mirum Pharmaceuticals, Inc.
Collaborator
Source ClinicalTrials.gov
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