Maralixibat for Intrahepatic Cholestasis of Pregnancy (METAPHOR)

Imperial College London

Status and phase: Begins enrollment in 1 month; Phase 2

Conditions: Intrahepatic Cholestasis of Pregnancy

Treatments: Drug: Maralixibat

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07389031

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1012589

Details and patient eligibility

About

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

Enrollment: 28 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

1. 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.
2. Known non-reassuring fetal status based upon antepartum testing (e.g., NST/CTG) at or within 7 days before the baseline visit.
3. Known fetal anomaly likely to result in intrauterine fetal demise or neonatal death within the first 30 days of life.
4. 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

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

Maralixibat

Experimental group

Description:

Dose-titrated open-label maralixibat, with primary assessment at Week 3; participants may continue treatment until delivery

Treatment:

Drug: Maralixibat