NCT00922207

A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 280 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Adefovir	From week -4 to week 2
DRUG	Entecavir	From week -4 to week 2
DRUG	Placebo	From week -4 to week 2
DRUG	peginterferon alfa-2a [Pegasys]	180 micrograms sc weekly, from week 1-48

Timeline

• Start date: 2010-05-07
• Primary completion: 2014-09-29
• Completion: 2014-09-29
• First posted: 2009-06-17
• Last updated: 2017-04-10
• Results posted: 2015-11-20

Locations

9 sites across 1 country: Taiwan