Overview

HBsAg Related Response Guided Therapy

Status:
Unknown status
Trial end date:
2016-08-01
Target enrollment:
Participant gender:
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
Phase:
Phase 4
Details
Lead Sponsor:
Gangnam Severance Hospital
Collaborator:
Roche Pharma AG
Treatments:
Entecavir
Interferon-alpha
Peginterferon alfa-2a