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Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin)

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Trial Profile

Randomised, Placebo-controlled, Multi-centre Study to Assess the Efficacy and Safety of Eltrombopag in Thrombocytopenic Subjects With Hepatitis C Virus (HCV) Infection Who Are Otherwise Eligible to Initiate Antiviral Therapy (Peginterferon Alfa-2a Plus Ribavirin)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2021

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At a glance

  • Drugs Eltrombopag (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C; Thrombocytopenia
  • Focus Registrational; Therapeutic Use
  • Acronyms ENABLE-1
  • Sponsors GlaxoSmithKline

Most Recent Events

  • 24 Sep 2013 Results from this trial supported the approval of a marketing authorisation application for eltrombopag with the European Commission for treating chronic hepatitis C-associated thrombocytopenia according to a GlaxoSmithKline media release.
  • 25 Mar 2013 New source identified and integrated (Clinical Trials Registry - India, CTRI2009-091-000507).
  • 07 Jul 2012 Planned number of patients changed from 675 to 750 as reported by European Clinical Trials Database.

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