Trial · NCT07389031
Maralixibat for Intrahepatic Cholestasis of Pregnancy
NCT07389031, Phase 2, Not yet recruiting, Imperial College London
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Maralixibat for Intrahepatic Cholestasis of Pregnancy. Trials, record NCT07389031. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07389031
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Maralixibat for Intrahepatic Cholestasis of Pregnancy
- NCT number
- NCT07389031
- Status
- Not yet recruiting
- Phases
- Phase 2
- Enrollment
- 28 participants, estimated
- Lead sponsor
- Imperial College London
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Interventions
- Maralixibat
- First posted
- 2026-02-05
- Last updated
- 2026-02-05
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Assess the Safety and Tolerability of Maralixibat in Participants With ICP | Through to end of treatment, up to 21 weeks | 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 . |
| Secondary | Mean Change in the Weekly Average Worst Daily Itch Score as Measured by the Adult Itch Reported Outcome (5-D Itch Scale) | Through the end of treatment (up to 21 weeks). | 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) |
| Secondary | Mean Change in Total Serum Bile Acid (tSBA) Concentration | Baseline to Week 3 (minimum 7 days of treatment) | Mean change from baseline to Week 3 of the study treatment period in total tSBA concentration (minimum 7 days). |
| Other | Proportion of participants with a Composite Adverse Perinatal Outcome | Up to 28 days after delivery | Number of adverse outcomes recorded from baseline to birth visit/end of study |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07389031
GET https://conductscience.org/api/trials/v1/NCT07389031/registered