Efficacy Study of Sequential Therapy of Peginterferon Alfa-2a Following Entecavir in Patient With Chronic Hepatitis B.

Phase 3

• Conditions: Hepatitis B, Chronic
• Interventions: Drug: Pegylated interferon α-2a Monotreatment Group; Drug: Entecavir and Pegylated interferon α-2a Sequential Treatment Group

• Registration Number: NCT01220596
• Lead Sponsor: Hanyang University

Brief Summary

Evaluate the safety and efficacy of Peginterferon alfa-2a following Entecavir compared with Peginterferon alfa-2a monotherapy in patient with HBeAg positive chronic hepatitis B.

* Increased HBeAg seroconversion rate

* Increased HBsAg loss rate

* To define the best treatment condition for chronic HBV hepatitis patients

Detailed Description

Not available

Study Timeline

• Study Start: 2010-06
• Study First Submitted: 2010-10-13
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Status Verified: 2011-06
• Last Update Submitted: 2011-07-01
• Last Update Posted: 2011-07-04
• Primary Completion: 2013-06
• Study Completion: 2013-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 228

Inclusion Criteria

• Chronic hepatitis B patients with HBeAg positive, HBsAg positive, HBV DNA > 100,000 copies/ml and anti-HBs negative, serum ALT exceeding 2 X ULN but less than 10 X ULN.

Exclusion Criteria

• Patient infected concurrently with HCV, HDV and HIV or patient with a history of antiviral treatment for Hepatitis B or patient with hepatic decompensation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Peginterferon alfa-2a monotherapy	Pegylated interferon α-2a Monotreatment Group	Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
Sequential therapy	Entecavir and Pegylated interferon α-2a Sequential Treatment Group	Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks

Primary Outcome Measures

Name	Time	Method
HBeAg seroconversion	24 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
the change of HBsAg titer	24 weeks after treatment
the rate of combined HBeAg seroconversion and HBV DNA < 300 copies/ml	24 weeks after treatment
The rate of serum HBV DNA < 300 copies	24 weeks after treatment
The rate of ALT normalization	24 weeks after treatment
The rate of HBsAg loss	24 weeks after treatment

Trial Locations

Locations (20)

Busan National University Yangsan Hospital; 🇰🇷 Yangsan, Gyeongsangnam-do, Korea, Republic of

Hanyang University Guri Hospital; 🇰🇷 Guri, Gyeonggi-do, Korea, Republic of

Wonju Christian Hospital; 🇰🇷 Wonju, Gangwon-do, Korea, Republic of

Bundang CHA medical center; 🇰🇷 Sungnam, Gyeonggi-do, Korea, Republic of

Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon-do, Korea, Republic of

Soon Chun Hyang University Bucheon Hospital; 🇰🇷 Bucheon, Gyeonggi-do, Korea, Republic of

Jeju National University Hospital; 🇰🇷 Jeju, Jeju-do, Korea, Republic of

Dong-A University Medical Center; 🇰🇷 Busan, Korea, Republic of

Yeungnam University Medical Center; 🇰🇷 Daegu, Korea, Republic of

Inje University Haeundae Paik Hospital; 🇰🇷 Busan, Korea, Republic of

Kyungpook National University Hospital; 🇰🇷 Daegu, Korea, Republic of

Kosin University Gospel Hospital; 🇰🇷 Busan, Korea, Republic of

Hanyang University Hospital; 🇰🇷 Seoul, Korea, Republic of

Kangbuk Samsung Hospital; 🇰🇷 Seoul, Korea, Republic of

Kyunghee university Medical Center; 🇰🇷 Seoul, Korea, Republic of

Kangdong Sacred Heart Hospital; 🇰🇷 Seoul, Korea, Republic of

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

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Inje University Sanggye Paik Hospital; 🇰🇷 Seoul, Korea, Republic of

Dankook University Hospital; 🇰🇷 Cheonan, Chungcheongnam-do, Korea, Republic of