NCT07585097

Brief Summary

This study will collect information from patients with ALGS who are using odevixibat in their daily lives. Odevixibat is a medication that helps patients with ALGS, a rare disease that affects the liver and causes itching. The main aim of this study is to observe the long-term, everyday safety of the drug odevixibat in patients with ALGS who are receiving ongoing treatment.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
61mo left

Started Sep 2026

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 13, 2026

Completed
5 months until next milestone

Study Start

First participant enrolled

September 30, 2026

Expected
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2031

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2031

Last Updated

May 13, 2026

Status Verified

May 1, 2026

Enrollment Period

5 years

First QC Date

May 6, 2026

Last Update Submit

May 6, 2026

Conditions

Alagille Syndrome

Outcome Measures

Primary Outcomes (2)

  • Percentage of participants experiencing adverse events (AEs)

    An adverse event (AE) is any untoward medical occurrence in a participant administered odevixibat, whether or not considered related to treatment.

    From first ICF signature and up to end of data collection (approximately 5 years of data collection)

  • Percentage of participants experiencing serious adverse events (SAEs)

    An adverse event (AE) is any untoward medical occurrence in a participant administered odevixibat, whether or not considered related to treatment.

    From first ICF signature and up to end of data collection (approximately 5 years of data collection)

Secondary Outcomes (26)

  • Percentage of participants with severe diarrhoea events

    From first ICF signature and up to end of data collection (approximately 5 years of data collection)

  • Percentage of participants with bloody diarrhoea events

    From first ICF signature and up to end of data collection (approximately 5 years of data collection)

  • Percentage of participants experiencing diarrhoea events with concurrent dehydration

    From first ICF signature and up to end of data collection (approximately 5 years of data collection)

  • Percentage of participants experiencing diarrhoea events treated with oral or intravenous rehydration

    From first ICF signature and up to end of data collection (approximately 5 years of data collection)

  • Change from baseline in fat-soluble vitamin (FSV) levels

    From baseline and up to end of data collection (approximately 5 years of data collection)

  • +21 more secondary outcomes

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants with Alagille syndrome (ALGS) who have been prescribed odevixibat by their treating physician will be enrolled into the study. Participants who started odevixibat treatment before study implementation may also be enrolled.

You may qualify if:

  • Diagnosed with ALGS.
  • On (or starting) active odevixibat treatment.
  • Aged 6 months or older at the time of consent.

You may not qualify if:

  • Currently participating in a clinical trial with odevixibat.
  • Currently participating in any interventional clinical trial for ALGS.
  • Have any contraindication to odevixibat as per the locally approved label.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Alagille Syndrome

Condition Hierarchy (Ancestors)

Cholestasis, IntrahepaticCholestasisBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesLiver DiseasesHeart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesAbnormalities, MultipleCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • Ipsen Medical Director

    Ipsen

    STUDY DIRECTOR

Central Study Contacts

Ipsen Clinical Study Enquiries

CONTACT

See e mailclinical.trials@ipsen.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2026

First Posted

May 13, 2026

Study Start (Estimated)

September 30, 2026

Primary Completion (Estimated)

September 30, 2031

Study Completion (Estimated)

September 30, 2031

Last Updated

May 13, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, annotated case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of study participants.

Time Frame
Where applicable, data from eligible studies are available 6 months after the studied medicine and indication have been approved in the US and/or EU.
Access Criteria
Further details on Ipsen's sharing criteria and process for sharing are available here (https://www.ipsen.com/science/clinical-trials/clinical-data-transparency/).
More information