Not yet recruiting NCT07389031
Maralixibat for Intrahepatic Cholestasis of Pregnancy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Maralixibat.
- Who it may be relevant to
- Registry conditions: Intrahepatic Cholestasis of Pregnancy. Basic parameters: 18 years — 50 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Maralixibat for the trEatment of inTrAhePatic cHOlestasis of pRegnancy (METAPHOR)
Overview
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
- Drug Maralixibat
Oral solution, dose-titrated. Maralixibat is an ileal bile acid transporter (IBAT) inhibitor.
Primary outcome measures
- Assess the Safety and Tolerability of Maralixibat in Participants With ICP [Time frame: Through to end of treatment, up to 21 weeks]
Secondary outcome measures (2)
- Mean Change 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 [Time frame: Baseline to Week 3 (minimum 7 days of treatment)]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United Kingdom · 2 centers
- Birmingham Womens and Childrens NHS Foundation Trust — Birmingham
- Guy's and St Thomas' NHS Foundation Trust — London
Identifiers
NCT: NCT07389031 · 1012589 · X