NCT01220596

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

A Randomized, Multi Center, Phase IIIb Open-label Study to Evaluate the Efficacy of Sequential Therapy of Peginterferon Alfa-2a(Pegasys(TM)) Following Entercavir Compared With Peginterferon Alfa-2a Monotherapy in Patient With HBeAg Positive Chronic Hepatitis B.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Hanyang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	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
DRUG	Pegylated interferon α-2a Monotreatment Group	Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks

Timeline

• Start date: 2010-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2010-10-14
• Last updated: 2011-07-04

Locations

20 sites across 1 country: South Korea