NCT01524679

Peg-interferon ADDed to an Ongoing Nucleos(t)Ide Based Treatment in Patients With Chronic Hepatitis B to Induce Decrease of HBs-Antigen

A Prospective, Randomised, Open-label Phase IIb Clinical Trial Assessing the Effect of Pegylated Interferon Alfa-2a (Pegasys®)180 μg Once Weekly for 48 Weeks in Addition to an Ongoing Nucelos(t)Ide Based Treatment on Quantitative HBsAg Levels in Patients With Chronic HBeAg-negative Hepatitis B

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 170 (actual)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

A prospective, randomised, open-label phase IIb clinical trial assessing the effect of pegylated interferon alfa-2a(Pegasys®) 180 μg once weekly for 48 weeks added to an ongoing nucleos(t)ide based treatment in patients with chronic HBeAg-negative hepatitis B The primary objective of the trial is to investigate whether the add-on of pegylated interferon alfa-2a to a continued treatment with nucleos(t)ide analogues increases the percentage of patients who have significant decrease (≥ 1log10) of HBs antigen after 48 weeks. 170 Patients with chronic hepatitis B, HBe antigen negative, already being treated with an oral antiviral regimen and having a nondetectable viral load for at least 12 months are included.

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Pegylated interferon alfa-2a plus nucleos(t)ide(s)	Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)

Timeline

• Start date: 2012-08-01
• Primary completion: 2017-08-28
• Completion: 2017-08-28
• First posted: 2012-02-02
• Last updated: 2020-02-18
• Results posted: 2020-02-18

Locations

24 sites across 1 country: Germany