Maralixibat for Intrahepatic Cholestasis of Pregnancy
Starting soon · Phase 2
Conditions studied: Intrahepatic Cholestasis of Pregnancy
In brief
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
Key facts
- Study ID
- NCT07389031
- Run by
- Imperial College London
- People needed
- 28
- Starts
- 2026-04-01
- Expected to finish
- 2028-03-31
- Last updated by the study team
- 2026-02-05
Who can join
Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
- Meets all inclusion criteria and no exclusion criteria at screening as well as at the Day 1 (baseline) visit, unless otherwise specified.
You may not qualify if…
- 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.
Where it is running
- Birmingham Womens and Childrens NHS Foundation Trust — Birmingham, United Kingdom
- Guy's and St Thomas' NHS Foundation Trust — London, United Kingdom
Full record on ClinicalTrials.gov
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