Maralixibat (Livmarli) use in Alagille syndrome and PFIC — Japanese database analysis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational database analysis uses the Comprehensive and Informative Registry system for Childhood Liver Disease (CIRCLe) in Japan to identify patients diagnosed with ALGS or PFIC who were prescribed maralixibat during the enrollment period. The index date is the first prescription of Livmarli, and existing medical records will be reviewed to document occurrences of liver disorders during treatment. No exclusion criteria are specified and the work involves retrospective data analysis rather than new interventions or visits. The project is sponsored by Takeda and aims to estimate the risk profile of maralixibat in a Japanese patient cohort.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Has a diagnosis of ALGS or PFIC within the enrollment period.
* There is a prescription for Livmarli during the enrollment period (Index date: the date of the first prescription within the enrollment period).

Exclusion Criteria:

\- None

Where it's running

• Takeda selected site
  Tokyo, Tokyo, Japan Recruiting

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Canadian pediatric registry for Alagille syndrome and genetic intrahepatic cholestasis

  This registry collects long-term health and genetic information from children in Canada who have Alagille syndrome or genetic intrahepatic cholestasis to better track outcomes and support research.

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• Odevixibat for PFIC in China: Real-world Safety and Effectiveness

  This registry collects real-world safety and effectiveness data on children with PFIC who are being treated with odevixibat in China.

  Recruiting at 2 sites Ipsen · Beijing and 5 other locations · NCT07588880

• Finding genetic causes of adult-onset cholestatic liver disease

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  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan, Milano · NCT07317193

• Long-term safety and outcomes of Livmarli for Alagille syndrome in the EU

  This study will follow people with Alagille syndrome who take Livmarli to see if it is safe, well tolerated over the long term, and continues to reduce cholestatic itching.

  Recruiting at 13 sites Phase 4 Mirum Pharmaceuticals, Inc. · Brussels and 14 other locations · NCT07290257

• Long-term outcomes of odevixibat (Bylvay) for people with PFIC in South Korea

  This registry will see how well odevixibat controls symptoms and how safe it is over time for people with Progressive Familial Intrahepatic Cholestasis (PFIC) in South Korea.

  Recruiting at 2 sites Ipsen · Gyeongsang and 4 other locations · NCT07185919

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.