NCT00940485

A Study of Combination or Sequential Treatment With PEGASYS (Peginterferon Alfa-2a) and Entecavir in Patients With HBeAg Positive Chronic Hepatitis B

A Study on Optimizing HBeAg Seroconversion in HBeAg Positive CHB Patients With Combination or Sequential Treatment of Pegylated Interferon Alpha-2a and Entecavir

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This 2 arm study will assess the efficacy and safety of Pegasys in combination or sequential treatment with entecavir in patients with HBeAg positive chronic hepatitis B. Patients who have been pretreated with, and responded to, entecavir for 9 to 36 months were randomized to one of 2 groups, to receive Pegasys 180micrograms/week sc for 48 weeks + entecavir 0.5mg po daily for 8 weeks, or entecavir 0.5mg po daily for 48 weeks. The anticipated time on study treatment is 3-12 months.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	entecavir	0.5mg po daily for 8 weeks
DRUG	entecavir	0.5mg po daily for 48 weeks
DRUG	peginterferon alfa-2a [Pegasys]	180 micrograms sc/week for 48 weeks

Timeline

• Start date: 2009-04-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2009-07-16
• Last updated: 2016-03-25
• Results posted: 2016-02-22

Locations

7 sites across 1 country: China