A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary Cirrhosis

Trial Profile

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate LUM001, an Apical Sodium-dependent Bile Acid Transporter Inhibitor (ASBTi) in Combination With Ursodeoxycholic Acid (UDCA) in Patients With Primary Biliary Cirrhosis

Completed
Phase of Trial: Phase II

Latest Information Update: 04 Aug 2015

At a glance

  • Drugs Lopixibat chloride (Primary) ; Ursodeoxycholic acid
  • Indications Primary biliary cirrhosis
  • Focus Therapeutic Use
  • Acronyms CLARITY; PBC
  • Sponsors Lumena Pharmaceuticals
  • Most Recent Events

    • 09 Apr 2015 Status changed from active, no longer recruiting to completed, according to ClinicalTrials.gov record.
    • 18 Mar 2015 Planned End Date changed from 1 Mar 2015 to 1 Aug 2015 as reported by ClinicalTrials.gov record.
    • 10 Dec 2014 Shire expects to report top-line results in the first half of 2015.
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