Trial · NCT07290257
Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU)
NCT07290257, Phase 4, Recruiting, Mirum Pharmaceuticals, Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU). Trials, record NCT07290257. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07290257
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-Term Low-Intervention SafEty and Clinical Outcomes Clinical Study of LivmArli® in Patients With Alagille Syndrome or Progressive Familial Intrahepatic Cholestasis in the European Union (LEAP-EU)
- NCT number
- NCT07290257
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 230 participants, estimated
- Lead sponsor
- Mirum Pharmaceuticals, Inc.
- Conditions
- Alagille Syndrome, Progressive Familial Intrahepatic Cholestasis
- Interventions
- Livmarli Oral Product
- First posted
- 2025-12-18
- Last updated
- 2026-06-23
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Adverse Events (AEs) | Up to 7 days after the last dose of Livmarli. | Number and proportion of participants with AEs. |
| Primary | Liver function tests (LFTs) - measuring enzyme activity or concentration | Once every 3-4 months, for 5 years. | Change in LFTs from Baseline: Total and direct bilirubin |
| Primary | Liver function tests (LFTs) - measuring enzyme activity or concentration | Once every 3-4 months, for 5 years. | Change in LFTs from Baseline: Aminotransferases and GGT. |
| Primary | Fat-Soluble Vitamins (FSV) Concentration | Once every 3-4 months, for 5 years. | Change in FSV levels (vitamins A, D, and E) from Baseline. |
| Primary | International Normalized Ratio (INR) | Once every 3-4 months, for 5 years. | Change in INR level from Baseline. |
| Primary | Long-Term Clinical Outcomes | Once every 3-4 months, for 5 years. | Number of participants with surgical biliary diversion, liver transplantation, liver transplant waitlist status change, clinically evident portal hypertension, complications of liver cirrhosis, liver carcinoma, liver decompensation, and death. |
| Primary | Laboratory Test for Monitoring of Propylene Glycol Toxicity in Participants with PFIC | Once every 3-4 months, for 5 years. | Change in PG level from Baseline. |
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/NCT07290257
GET https://conductscience.org/api/trials/v1/NCT07290257/registered