drugset / Trial / NCT01456312
HBsAg Related Response Guided Therapy
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Entecavir | Small molecule | — | — |
| Comparator | Peginterferon alfa-2a | Protein / enzyme biologic | — | — |