NCT01456312

HBsAg Related Response Guided Therapy

A Multi Center, Phase IIIb Study to Evaluate the Efficacy of Response Guided Therapy Using Quantitative HBsAg Measurement in Patient With HBeAg Positive Chronic Hepatitis B:

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Gangnam Severance Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2a	Duration and combination
DRUG	Entecavir	combination

Timeline

• Start date: 2012-09-01
• Primary completion: 2016-02-01
• Completion: 2016-08-01
• First posted: 2011-10-20
• Last updated: 2012-10-31

Locations

1 site across 1 country: South Korea