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Clinical Trial 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 ⅲ. The rate of serum HBV DNA < 300 copies/mL

- The rate of ALT normalization ⅴ. The rate of HBsAg loss ⅵ. The rate of serum HBV DNA < 10,000 copies/mL


Clinical Trial Description

After 12w treatment of Pegasys, depends on results of quantitative HBsAg test, Patients will be allocated to one of three groups.

- HBsAg >20,000 : study termination

- Group A :1,500<HBsAg≤ 20,000

- Group B : .HBsAg ≤ 1500 At week 48, according to HbeAg seroconversion, patients will be allocated to one of two sub-groups(A-1, A-2, B-1, B-2) Patients are seen for evaluation at treatment weeks 4,8,12,24,36,48. Post-treatment assessments will be performed at 4,12 and 24 week during off-treatment phase for the assessment of the primary and main secondary endpoints of the study. ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01456312
Study type Interventional
Source Gangnam Severance Hospital
Contact Kwansik Lee, professor
Phone +82 11 9636 9935
Email leeks519@yuhs.ac
Status Recruiting
Phase Phase 4
Start date September 2012
Completion date August 2016

See also
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