Long-Term, Open-Label Study With a Double-Blind, Placebo-Controlled, Randomized Drug Withdrawal Period of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Alagille Syndrome

Trial Profile

Long-Term, Open-Label Study With a Double-Blind, Placebo-Controlled, Randomized Drug Withdrawal Period of LUM001, an Apical Sodium-Dependent Bile Acid Transporter Inhibitor (ASBTi), in Patients With Alagille Syndrome

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 30 Sep 2017

At a glance

  • Drugs Lopixibat chloride (Primary)
  • Indications Alagille syndrome; Cholestasis; Pruritus
  • Focus Therapeutic Use
  • Acronyms ICONIC
  • Sponsors Lumena Pharmaceuticals; Shire
  • Most Recent Events

    • 30 Nov 2016 Time frame of primary end points has been changed from 4 weeks to 48 weeks.
    • 14 Apr 2016 Planned End Date changed from 1 Mar 2016 to 1 Sep 2017.
    • 17 Aug 2015 Status changed from recruiting to active, no longer recruiting, as reported by ClinicalTrials.gov.
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