NCT02474316

Combined Therapy With Peginterferon Alfa-2a With NA in NA-treated HBeAg Positive Patients

A Prospective, Randomized, Multicenter, Open-label Study Evaluating HBeAg Seroconversion in HBeAg Positive CHB Patients on Treatment With NA Switched to Combined Therapy With Peginterferon Alfa-2a and NA for 48 Weeks

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 366 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA\<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows: Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1 piece qd for 48 weeks Arm B: Entecavir 0.5mg qd for 48 weeks

Detailed description

This is a prospective, randomized, multicenter, open-label study. After more than 24 weeks NA treatment, HBeAg positive CHB patients who achieved HBV DNA\<1000copies/ml but HBeAb negative, will be randomized (1:1) into 2 study arms as follows: Arm A: Peginterferon alfa-2a 180μg /wk plus NA 1piece qd for 48 weeks Arm B:NA 1 piece qd for 48 weeks The primary endpoint: HBeAg seroconversion at week 48

Conditions

• Chronic Hepatitis B

Interventions

Type	Name	Description
DRUG	Peginterferon alfa-2a	Peginterferon alfa-2a 180ug/wk s.c for 48 weeks
DRUG	nucleos(t)ide analgoue	nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks

Timeline

• Start date: 2014-08-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2015-06-17
• Last updated: 2015-12-03

Locations

3 sites across 1 country: China