A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis

Trial Profile

A Study of INT-747 (6-ECDCA) Monotherapy in Patients With Primary Biliary Cirrhosis

Completed
Phase of Trial: Phase II

Latest Information Update: 25 May 2017

At a glance

  • Drugs Obeticholic acid (Primary)
  • Indications Primary biliary cirrhosis
  • Focus Therapeutic Use
  • Sponsors Intercept Pharmaceuticals
  • Most Recent Events

    • 07 Jun 2017 Biomarkers information updated
    • 25 May 2017 According to an Intercept Pharmaceuticals media release, the Health Canada has granted a conditional approval for Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC), when used in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA. Data from the study supported the application.
    • 18 Mar 2017 Results evaluating evidences from NCT01904539, NCT01473524, NCT00550862, NCT00570765 trials to recommend appropriate dosing in treatment of primary biliary cholagitis, presented at the 118th Annual Meeting of the American Society for Clinical Pharmacology and Therapeutics
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