drugset / Trial / NCT01456312

HBsAg Related Response Guided Therapy

NCT01456312

Non-randomizedParallel-groupOpen-labelTreatment

Summary

Primary objective: Compare Pegasys RGT overall response rate (i.e., HBeAg seroconversion rate) with Pegasys mono historical response rate at week 72 (48 week treatment with 24 week follow up) Secondary objective : * The changes of HBsAg titer * The rate of combined HBeAg seroconversion and HBV DNA \< 300 copies/mL * The rate of serum HBV DNA \< 300 copies/mL ⅳ. The rate of ALT normalization * The rate of HBsAg loss ⅵ. The rate of serum HBV DNA \< 10,000 copies/mL

Timeline

Start
2012-09
Primary completion
2016-02
Completion
2016-08

Drugs

EvaluationDrugModalityDoseRoute
Comparator Entecavir Small molecule
Comparator Peginterferon alfa-2a Protein / enzyme biologic