A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon alpha-2a (Pegasys) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon alpha-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

Trial Profile

A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination With Peginterferon alpha-2a (Pegasys) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon alpha-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

Completed
Phase of Trial: Phase IV

Latest Information Update: 17 Nov 2015

At a glance

  • Drugs Peginterferon alfa-2a (Primary) ; Tenofovir disoproxil fumarate (Primary)
  • Indications Hepatitis B
  • Focus Therapeutic Use
  • Acronyms TDF PEG CHB
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 10 Aug 2015 Status changed from active, no longer recruiting to completed according to ClinicalTrials.gov record.
    • 24 Sep 2014 Planned End Date changed from 1 Sep 2015 to 1 Jul 2015 according to ClinicalTrials.gov record.
    • 24 Sep 2014 Planned primary completion date changed from 1 Jul 2015 to 1 Aug 2014 according to ClinicalTrials.gov record.
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