NCT01179594

A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.

A Phase IV, 2x2 Factorial, Double Blind Study of 48 Versus 96 Weeks of PEGASYS 180µg, With or Without 24 Weeks of Entecavir in Adult Patients With HBeAg Negative Chronic Hepatitis B.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a \[Pegasys\], with or without entecavir, in patients with HbeAg negative chronic hepatitis B. Patients will be randomly allocated to receive Pegasys (180mcg subcutaneously weekly) for 48 weeks plus placebo (group A) or entecavir (0,5mg orally daily, group B) during weeks 12-36, or Pegasys (180mcg subcutaneously weekly) for 96 weeks plus placebo (group C) or entecavir (group D) during weeks 12-36. Anticipated time on study treatment is 48 or 96 weeks, with a follow-up of 48 weeks. Target sample size is \<500 patients.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	entecavir	0.5 mg orally daily, 24 weeks (weeks 12-36)
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg sc weekly, 48 weeks
DRUG	peginterferon alfa-2a [Pegasys]	180 mcg sc weekly, 96 weeks
DRUG	placebo	orally daily, 24 weeks (weeks 12-36)

Timeline

• Start date: 2010-09-18
• Primary completion: 2014-11-01
• Completion: 2014-11-01
• First posted: 2010-08-11
• Last updated: 2017-02-17