drugset / Trial / NCT01243281

Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B

NCT01243281

Unknown 126 enrolled Chulalongkorn University
RandomizedParallel-groupSingle-blindTreatment

Summary

The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate. In addition, the simultaneous assessment of viral and host genetic factors associated with SVR may help to identify predictors of treatment outcomes, which will in turn significant reduce the cost/effect of therapy

Timeline

Start
2011-03
Primary completion
2013-05
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Entecavir Small molecule 0.5 mg
Comparator Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg