Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2025-12-24 @ 6:42 PM
NCT ID:
NCT07290257
Eligibility Criteria:
Inclusion Criteria:
* Informed consent and assent (as applicable)
* ≥2 months of age at Day 1
* A clinically and/or genetically confirmed ALGS diagnosis with pruritus secondary to chronic cholestasis
* For the primary cohort, prescribed Livmarli at time of study entry
* For the supplemental cohort, prescribed Livmarli prior to study entry
Exclusion Criteria:
* History of Liver Transplant
* Any contraindications against Livmarli (as per SmPC)
* Any condition or abnormality that, in the opinion of the investigator, may interfere with the participation in or completion of the study
* Received an investigational drug within 30 days before the first dose of Livmarli (Participation in previous maralixibat studies or expanded-access programs is acceptable.)
* Baseline data before start of treatment of Livmarli are unavailable (\<2 values before treatment) for key safety (LFTs, FSV laboratory results) and key efficacy (sBA, pruritus) parameter
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Months
Study:
NCT07290257
Study Brief:
Protocol Section:
NCT07290257