NCT01086085

A Study of Peginterferon Alfa-2a [PEGASYS] in Patients With Chronic Hepatitis B Who Are HBeAg Positive

A Study on Optimizing the Treatment in HBeAg Positive CHB Patients With Response Guide Treatment (RGT) Method.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 265 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This open-label, multi-center study will evaluate the effect on the quantitative HBsAg reduction of peginterferon alfa-2a \[PEGASYS\] in patients with HBeAg positive chronic hepatitis B. Patients will receive PEGASYS 180 mcg sc once weekly. After 24 weeks of treatment, rapid responders will receive another 24 weeks of treatment. After 24 weeks of treatment, slow responders will be randomized to another 24 or 72 weeks of PEGASYS monotherapy, or to 72 weeks PEGASYS plus 36 weeks adefovir (10 mg, po once daily, starting from week 29 of PEGASYS treatment). The anticipated time on study drug is \>2 years.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Adefovir	Adefovir 10 mg po once daily for 36 weeks
DRUG	peginterferon alfa-2a [PEGASYS]	Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
DRUG	peginterferon alfa-2a [PEGASYS]	Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
DRUG	peginterferon alfa-2a [PEGASYS]	Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks

Timeline

• Start date: 2010-04-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2010-03-12
• Last updated: 2016-11-02

Locations

11 sites across 1 country: China