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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 α-2a (Pegasys) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

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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 α-2a (Pegasys) Versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon α-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB)

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 08 Aug 2023

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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

  • 24 Jun 2023 Results assessing whether Serum-based Exosome-seq reveals liver-associated signatures of response to PEG-IFN treatment in CHB patients, presented at the European Association for the Study of the Liver Congress 2023
  • 29 Aug 2020 Results defining the full sequences of integrated HBV DNA and comparing these sequences with data from RNA Seq to determine productive vs non productive integrations presented at The International Liver Congress 2020
  • 29 Aug 2020 Results from GS-US-174-0149 (n=30) evaluating peripheral soluble protein, transcriptomic, and methylation biomarkers associated with HBsAg loss in patients with chronic hepatitis B, presented at The International Liver Congress 2020

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