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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)

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Trial Profile

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)

Status: Recruiting
Phase of Trial: Phase IV

Latest Information Update: 25 Jun 2026

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At a glance

  • Drugs Maralixibat (Primary)
  • Indications Alagille syndrome; Intrahepatic cholestasis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms LEAP-EU
  • Sponsors Mirum Pharmaceuticals

Most Recent Events

  • 03 Jun 2026 The protocol has been amended to include patient with Progressive Familial Intrahepatic Cholestasis (PFIC) as well. Hence there is also an increase in the planned patient number.
  • 03 Jun 2026 Planned number of patients changed from 100 to 230.
  • 10 Sep 2025 New trial record

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