drugset / Trial / NCT01641926

A Study of the Safety and Efficacy of Pegylated Inferferon Alfa-2b (PEG-Intron™) Versus Pegylated Interferon Alfa-2a (PEGASYS™) in Participants With Chronic Hepatitis B (P08450)

NCT01641926

Phase 3 Terminated 402 enrolled Merck Sharp & Dohme LLC
RandomizedParallel-groupOpen-labelTreatment

Summary

This study is being done to compare the safety and efficacy of PEG-Intron™ to that of PEGASYS™ in participants with chronic hepatitis B (hepatitis B envelope antigen \[HBeAg\] positive or negative) who have not previously been treated with interferon.

Timeline

Start
2012-11-26
Primary completion
2016-01-21
Completion
2016-01-21

Drugs

EvaluationDrugModalityDoseRoute
Comparator Peginterferon alfa-2a Protein / enzyme biologic 180 ug/kg Subcutaneous
Subject Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg Subcutaneous