A single-arm, multinational, two year study evaluating the efficacy and safety of lead-in telbivudine for 24 weeks with or without tenofovir treatment intensification in adult patients with HBeAg (hepatitis B e antigen) -positive chronic hepatitis B.

Trial Profile

A single-arm, multinational, two year study evaluating the efficacy and safety of lead-in telbivudine for 24 weeks with or without tenofovir treatment intensification in adult patients with HBeAg (hepatitis B e antigen) -positive chronic hepatitis B.

Completed
Phase of Trial: Phase IV

Latest Information Update: 05 May 2014

At a glance

  • Drugs Telbivudine (Primary) ; Tenofovir disoproxil fumarate
  • Indications Hepatitis B
  • Focus Therapeutic Use
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 06 Mar 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
    • 28 Mar 2012 Planned number of patients changed from 100 to 105 as reported by European Clinical Trials Database.
    • 01 Nov 2011 Planned end date changed from 1 Jul 2011 to 1 Jan 2012 as reported by ClinicalTrials.gov.
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