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More info
You can access this
clinical trial
if you have
Hepatitis B, Chronic
and you are
between 18 and 65
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

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.

Provided treatments

  • Drug: Adefovir
  • Drug: Entecavir
  • Drug: Placebo
  • Drug: peginterferon alfa-2a [Pegasys]
Tris trial is registered with FDA with number: NCT00922207. The sponsor of the trial is Hoffmann-La Roche and it is looking for 280 volunteers for the current phase.
Official trial title:
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