A Phase IIb, Open, Multinational, Multi-center, Randomised, Comparative, Parallel Study to Assess the Safety and Antiviral Activity of LB80380 Compared to Entecavir 0.5 mg in Chronic Hepatitis B Patients for 48 Weeks With a Planned Analysis of Efficacy and Safety at Week 24 of the Treatment for Selecting Optimal Dose.

Trial Profile

A Phase IIb, Open, Multinational, Multi-center, Randomised, Comparative, Parallel Study to Assess the Safety and Antiviral Activity of LB80380 Compared to Entecavir 0.5 mg in Chronic Hepatitis B Patients for 48 Weeks With a Planned Analysis of Efficacy and Safety at Week 24 of the Treatment for Selecting Optimal Dose.

Completed
Phase of Trial: Phase II

Latest Information Update: 25 Oct 2014

At a glance

  • Drugs Besifovir (Primary) ; Entecavir
  • Indications Hepatitis B
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors LG Life Sciences
  • Most Recent Events

    • 13 Apr 2012 Actual end date (1 May 2011) added as reported by ClinicalTrials.gov. (Parent trial: NCT01026610)
    • 13 Apr 2012 Actual end date (1 May 2011) added as reported by ClinicalTrials.gov. (Parent trial: NCT01026610)
    • 13 Apr 2012 Actual patient number is 115 as reported by ClinicalTrials.gov. (Parent trial: NCT01026610)
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