Chronic Hepatitis B Clinical Trial
Official title:
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)
This study will evaluate the safety and efficacy of tenofovir disoproxil fumarate (TDF) plus
peginterferon α-2a (PEG) combination therapy versus standard of care TDF monotherapy or PEG
monotherapy in non-cirrhotic adults with chronic hepatitis B virus (HBV).
The study will consist of 2 phases for participants in the TDF+PEG 48 week, TDF 48 week+PEG
16 week, and PEG 48 week groups. Following an initial 48 weeks of treatment, participants in
these groups will be monitored for 24 weeks for signs of worsening HBV, and those with new
signs and/or symptoms will be eligible to receive TDF monotherapy during a retreatment
phase, up to Week 120.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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