NCT01464281

A Study of Switch From Nucleotide to Peginterferon Alfa-2a in CHB Patients Achieving HBeAg Loss and HBV DNA <200IU/ml

A Randomized, Multicenter Study Evaluating HBsAg Clearance in CHB Patients Achieving HBeAg Loss and HBV DNA <200copies/ml on Treatment With Nucleotide Analogues and Switched to Peginterferon Alfa-2a

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: The Second Affiliated Hospital of Chongqing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A Randomized, open-label, multicenter study. The patients after 1-3 years NAs treatment and having achieved HBeAg loss and HBV DNA \<200IU/ml will be switched to Pegasys for 48 or 96 weeks (with a 12 weeks period of overlap with the NA for safety reasons). The subjects will be randomized into 2 groups: Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week. All the patients will be followed up for 48 weeks after discontinuation of the study medication. Note: NAs will be stratified LAM, ETV and ADV, with the ratio 1:1:1.

Detailed description

eligibility criteria: Men and women old of 18 to 65 years with chronic hepatitis B HBeAg positive treated with nucleoside and/or nucleotide analogues for 1-2 years and with partial response (HBeAg loss and HBV DNA \<1000copies/ml).

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Peginterferon alfa 2a	Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week.

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-06-01
• Completion: 2016-12-01
• First posted: 2011-11-03
• Last updated: 2011-11-03

Locations

1 site across 1 country: China