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Open Label Study of the Efficacy and Long Term Safety of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Patients With Progressive Familial Intrahepatic Cholestasis

Trial Profile

Open Label Study of the Efficacy and Long Term Safety of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in the Treatment of Cholestatic Liver Disease in Pediatric Patients With Progressive Familial Intrahepatic Cholestasis

Status: Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 15 Nov 2019

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At a glance

  • Drugs Lopixibat chloride (Primary)
  • Indications Intrahepatic cholestasis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms INDIGO
  • Sponsors Lumena Pharmaceuticals; Mirum Pharmaceuticals; Shire
  • Most Recent Events

    • 11 Nov 2019 Planned End Date changed from 31 Dec 2019 to 29 Feb 2020.
    • 11 Nov 2019 Planned primary completion date changed from 31 Dec 2019 to 29 Feb 2020.
    • 08 Nov 2019 According to an Mirum Pharmaceuticals media release, results from this study will be presented at the annual meeting of the American Association of the Study of Liver Diseases (the Liver Meeting) in Boston
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