NCT01706575

A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression

A Phase IIb, Open Label, Single Arm, Multicenter Study to Evaluate the Effect of 48-weeks PEG-Interferon Alfa-2a (PEG-IFN) Administration on Serum HBsAg in Chronic Hepatitis B, HBeAg-Negative, Genotype D Patients on Treatment With Nucleos(t)Ide Analogues (NAs), Showing Stable HBV DNA Suppression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 76 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg decline \<0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the participants will continue their NA treatment.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Pegylated Interferon (Peginterferon) Alfa-2a	Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.
DRUG	Nucleos(t)ide Analogues (NA)	Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-09-01
• Completion: 2014-11-01
• First posted: 2012-10-15
• Last updated: 2017-02-20
• Results posted: 2016-08-05

Locations

27 sites across 1 country: Italy