At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-label Study of the Effect of Peginterferon Alfa-2a (40KD)(PEGASYS) in Combination With Adefovir or Entecavir on HBeAg Seroconversion in Patients With HBeAg Positive Chronic Hepatitis B
In Brief
A Phase 4 clinical trial evaluating Adefovir, Entecavir, and 2 other interventions for Hepatitis B, Chronic. Completed, enrolled 280 participants across 9 sites.
Detailed Summary
This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B. Patients will be randomized to receive 1)PEGASYS 180 micrograms sc weekly for 48 weeks + placebo from weeks -4 to 2;2)PEGASYS 180 micrograms sc weekly for 48 weeks + Adefovir from weeks -4 to 2; or 3)PEGASYS 180 micrograms sc weekly for 48 weeks + Entecavir from weeks -4 to 2. Treatment will be followed by 24 weeks of treatment-free follow-up.The anticipated time on study treatment is 1 year, and the target sample size is 100-500 individuals.
Study Details
Timeline
Interventions
From week -4 to week 2
From week -4 to week 2
From week -4 to week 2
180 micrograms sc weekly, from week 1-48