HBsAg Related Response Guided Therapy

Phase 4

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Peginterferon alfa-2a; Drug: Entecavir

• Registration Number: NCT01456312
• Lead Sponsor: Gangnam Severance Hospital

Brief 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.

Study Timeline

• Study First Submitted: 2011-10-15
• Study First Submitted QC: 2011-10-19
• Study First Posted: 2011-10-20
• Study Start: 2012-09
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-29
• Last Update Posted: 2012-10-31
• Primary Completion: 2016-02
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Age ≥ 18 years
2. Positive HBsAg for more than 6 months, positive HBeAg, detectable HBV DNA(patients must have > 100,000 copies/ml as measured by PCR) and anti-HBs negative
3. Elevated serum ALT > 2ULN but ≤ 10 × ULN as determined by two abnormal values taken ≥ 14 days apart during the six months before the first dose of study drug with at least one of the determinations obtained ≤ 35 days prior to the first dose.

Exclusion Criteria

1. Patients must not have received antiviral therapy for their chronic hepatitis B. Patients who are expected to need systemic antiviral therapy other than that provided by the study at any time during their participation in the study are also excluded. Exception: patients who have had less than 6 months treatment of NA(Nucleos(t)ide analog) and more than 1 year wash-out period for systemic antiviral therapy and negative results in the NA resistance test at baseline are not excluded.
2. Positive test at screening for HAV IgM Ab, HCV-RNA or HCV Ab, HDV Ab or HIV Ab.
3. Diagnosed hepatic cellular carcinoma
4. Any evidence of decompensated liver disease (Childs B-C)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HBsAg<=1500IU/ml	Peginterferon alfa-2a	extend peginterferon alfa 2a until 48weeks
HBsAg quantification>20,000 IU/ml	Peginterferon alfa-2a	stop peginterferon alfa 2a if patients reach HBsAg quantification\>20,000 Iu/ml at 12w
HBsAg >1500 <=20,000 IU/ML	Entecavir	add Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w
HBsAg >1500 <=20,000 IU/ML	Peginterferon alfa-2a	add Entecavir for 12w with peginterferon alfa 2a then, extend peginterferon alfa 2a until 48w

Primary Outcome Measures

Name	Time	Method
HBeAg seroconversion	24 weeks post treatment follow up

Secondary Outcome Measures

Name	Time	Method
The changes of HBsAg titer	baseline and 24weeks post treatment follow up

Trial Locations

Locations (1)

Shinchon Severance Hospital; 🇰🇷 Seoul, Korea, Republic of