NCT00883844

PEG-IFN in HBV Patients With Incomplete Response to NA

Lowering Viral Load With Nucleos(t)Ide Analogues Prior to Peginterferon Alfa-2b Treatment to Increase Sustained Response in HBeAg-positive Chronic Hepatitis B - a Pilot Study

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Foundation for Liver Research · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Treatment with a nucleoside analogue and subsequent viral decline has shown to partially restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies investigating whether the effect of lowering viral load with nucleoside analogue therapy prior to the initiation of peginterferon results in higher sustained off-treatment responses showed contradictory findings. The aim of this study is to investigate sustained off-treatment response to peginterferon alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide analogues, thereby lowering viral load

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Nucleos(t)ide analogue treatment with a peginterferon add-on strategy	peginterferon 1.5 microgram/kg once a week Treatment with one of the approved nucleos(t)ide analogues
DRUG	Nucleos(t)ide analogue treatment	Treatment with one of the approved nucleos(t)ide analogues

Timeline

• Start date: 2009-04-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2009-04-20
• Last updated: 2013-04-19

Locations

2 sites across 1 country: Netherlands